Total 80 accounts manager job vacancies in Quality Assurance / Control category in Hong Kong, Hong Kong Island

1. Lead and support QC team for daily QC activities by ensuring timely analysis, documentation, and review of RM/PM/FP/IPC/Stability and Process validation samples as per predefined standards.
2. Write and / or review controlled documentation related to laboratory operations or testing such as SOP's, analytical protocols, analysis reports, forms and validation documents.
3. Ensure compliance with FDA/USP/EP/ICH/ChP regulations and internal controlled procedures in the QC Laboratory.
4. Ensure readiness of QC Laboratory in internal / external audits.
5. Maintain data integrity in Quality Control activities and ensure appropriate traceability.
6. Initiate change control documents.
7. Lead and participate in stability program, method validations, technical transfer, method transfer and validation / qualification activities at the site.
8. Participate in New Product Introduction activities.
9. Lead and participate in laboratory investigations. Document laboratory investigation activities or review and approve laboratory investigation reports.
10. Participate in site corrective action / preventive action (CAPA) program. Ensure timely completion of all commitments made under QMS.
11. Lead and participate in key performance indicators for improving laboratory efficiency, monitoring equipment performance.
12. Lead QC Department training program by imparting training to new staff and comply with Analyst Qualification procedure.
13. Escalate the quality events, trends as appropriate to QC Head.
14. Remain abreast of current regulatory, pharmacopeia and cGMP trends.
15. Serve as subject matter expert on laboratory instrumentation and compliance issues.
16. Lead the QC team, evaluate competencies, assign responsibilities, monitor performance, counsel and provide guidance. Plan & monitor the training and development requirements, motivate staff appropriately to build a committed, motivated & competent team.
17. Participate in personnel decisions (interviewing, hiring, performance appraisals, promotions, termination, staff development, improvement plans) regarding subordinate staff.
18. Maintains a safe laboratory environment by implementing recommendations made by EHS.
19. Initiate CAPEX for equipment purchases.
20. Support in budget preparation for QC Laboratory.
21. Any other activities as and when assigned by the Superior.

EDUCATION:

Degree in science or related discipline (e.g. Chemistry, Chemical Engineering).

EXPERIENCE:

Minimum 8 years of quality control experience in pharmaceutical manufacturing industry and minimum 2 years of supervisory experience in managing team.

KNOWLEDGE & SKILLS:

1. Possess working knowledge of GMP in the pharmaceutical industry.
2. Excellent interpersonal and analytical skills, good verbal, and written communication skills.
3. Working knowledge of qualification, calibration and operation of laboratory equipment such as HPLC, GC, FTIR and Dissolution equipment.
4. Working knowledge of method development, validation, verification of analytical method.
5. Familiarity of 21 CFR Part 11 requirements.

Quality Management System:

• Responsible for quality oversight of operations at PharmaGend Global Medical Services Pte Ltd facility. Adhere to laid down Quality Management System, its effective implementation and facilitate continuous improvement in all manufacturing area activities, and effective resolution of routine Quality issues.
• Tracking, trending and closing QMS events using TrackWise. Review and Approval of documentation associated with key quality compliance indicators - Deviation, Market Complaints, Product Recalls, CAPAs, Change Controls, Returned Goods and other quality system documents e.g., Product Quality Review, SOP's, Protocols, reports as appropriate; and actively participate in investigations.
• Subject matter expert in Qualification and Validation activities related to GMP area, production equipment and key utilities e.g., Purified water system, Compressed air system.
• Review periodically the Quality Performance parameters, review and approve appropriate remedial actions towards compliance and Quality of products supplied. Identify proactively the actions towards continuous improvement and measure performance of Quality through various tools / Quality Indicators.
• Escalate the quality events, trends as appropriate to various management levels in organization for appropriate regulatory actions as applicable and provide close-out actions as deemed necessary / required.
• Ensure timely review and / approval of executed batch records, and final batch release to market. and disposition (Release/Rejection) of in-process and finished product batches as appropriate.
• Implement ongoing process management mechanisms (process mapping, documentation, metrics, monitoring systems and process control techniques).
• Perform periodic review of Quality Performance parameters and approve appropriate remedial actions towards compliance and Quality of products supplied. Identify proactively the actions towards continuous improvement and measure performance of Quality through various tools / Quality Indicators, provide Quality Management Reports.
• Escalate the quality events, trends as appropriate to various management levels in organization for appropriate regulatory actions as applicable and provide close-out actions as deemed necessary / required.
• Conduct internal audits and/or vendor audits as required.
• Ensure the SOPs are in line with the practice and revision thereof if required.
• To ensure that the facility is kept all time ready to handle any regulatory, customer or internal audit.
• Act as a designee to for Head Quality on QMS related matters.

Documentation Compliance:

• Review and approval of master BMR/BPR and issuance of BMR/BPR.
• Control and Management of archived documents.
• Preparation and Review of SOPs/Work instructions and forms related to quality assurance and cross functional departments.
• Review and approval of protocol and reports.
• Ensure effective control of confidential and all technical documents and information networking, timely review and approval of relevant technical documents.

Quality Risk Management:

• Participate in Identification and implement risk approach in validation / qualification area based on overall risk management policy / guidelines to control / mitigate risks.
• Apply risk management tools and techniques.

People Management including Technical Training:

• Assign responsibilities, monitor performance, counsel & provide feedback on team performance, plan & monitor required training and development to ensure a committed & competent team.
• Build strong and positive cross-functional working relationships by working to include them in the improvement activities/training, making sure their needs and requirements are carefully considered.
• Conduct Technical Training (On the Job as well as Classroom) to fellow colleagues, new employees and cross functional team.

Management of interface with Regulators/Customers

• Interact with customers/regulatory bodies in a timely manner to address quality / technical related events to ensure desired outcome and adherence to regulatory commitment and compliance.
• Interpret current Regulatory guidance and implement at site.
• Management technical agreement with ESP and clients.
• Updating GMP Documents as per Regulatory amendments and process requirements.
• Ensure compliance with various regulatory commitments, regulatory requirements and customer requirements as applicable including policies.

Requirements:

• Bachelor’s degree and/or Maste’s degree in Pharmacy or Chemistry.
• At least 10 to15 years of experience, demonstrated ability to execute against the strategic and tactical objectives provided by senior leaders both within Quality and outside of the function.
• More than 8 years’ experience in pharmaceutical validation, qualification projects.
• In-depth understanding of Manufacturing/Pharma Business
• Strong team leadership skills
• Strong staff coaching and development skills.
• Strong ability to communicate.
• Strong ability to influence in a team environment and collaborate with peers.
• May participate in interactions with various governmental agencies/regulators and external auditors.
• Strong understanding of US FDA regulatory requirements.
• Serves as an active member of the Quality Management Team
• Serves as an expert to identify best practices across the organization, shares and implements as appropriate.
• Interacts with site efforts to ensure consistency in policies and practices.

Job Description:

• Responsible for implementing all QA/QC inspection and testing, as required by specifications or by regulatory requirements and shall be familiar with all aspects of testing required for commercial building including the quality testing requirements of local Authorities such as the Standards, Productivity and Innovation Board (SPRING Singapore)
• Monitor progress and quality of all C&S, Archi, M&E and security system works, including CONQUAS, Green Mark etc to ensure compliance to project and statutory requirements
• Review procedures to improve productivity.
• Attends meetings with client, authorities, subcontractors and consultants.
• Ad-hoc duties as assigned

Requirements (Qualification & Experience):

• Preferably university graduate in Electrical/Security/Computer Engineering or IT recognised by PEB Singapore.
• Ten (10) years of relevant experience in the implementation and management of quality control systems
• Familiar with BIM for construction, Green Mark, CONQUAS and relevant authority requirements
• Full time stationed on site during construction

Job Description & Responsibilities:

• Maintenance of Quality Management System ensuring compliance to internal, and international standards and regulatory requirements for medical devices.
• Develop QMS documents in line with business activity of DxD Hub.
• Work with technical team to create quality document related to product design, development and manufacturing, including product test/validation protocols, change management in compliance to applicable regulatory requirements.
• Develop and evaluate medical device regulatory intelligence and maximize opportunities to expedite the registration process within S.E.A region, China and USA. Activities include obtaining and maintaining domestic and regional market access for our innovative products.
• Provide appropriate inputs to assist in defining regulatory strategies and timelines for regulatory submissions for the total product lifecycle for medical devices.
• Compile technical, clinical and production protocols and documentations necessary for new products dossier submission to S.E.A. region, China and USA. regulatory submissions. Liaise with technical team (locally and internationally) on technical information required to prepare submission dossiers. Manage preparation (developing submission content, management of document legalization, and creation of any other documents required for submissions) and maintenance of regulatory submissions and other premarket registrations to acquire appropriate commercial distribution clearances in accordance with regulatory strategic plan.
• Overall responsible for ensuring that medical device files are set up in compliance to regulatory requirement.
• Monitor and communicate new and changing medical device law, guidance regulations in a timely manner. Reviews process change recommendation and assists in implementing new procedures and documentation.
• Ensure that regulatory records are controlled and maintained.
• Train internal and external stakeholders on regulatory data management processes and platforms, regulatory matters and product registration.

Job Requirements:

• Master or Bachelor of Science/Engineering with strong background in biomedical, computer or engineering sciences.
• Possess 3 years or more of working experience in quality assurance and regulatory affairs in medical devices; thorough working knowledge of ISO 13485:2016.
• Good working knowledge in managing QMS in a medical device environment in compliance to ISO 13485:2016.
• Competent in quality assurance methodologies.
• Working knowledge in QA processes for design, development and manufacturing of IVD, SaMD and Integrated Medical Technologies.
• Demonstrated skills in risk management (ISO 14971).
• Knowledge of Health Sciences Authority requirement for IVD product submission.
• Knowledge in regulatory requirements for medical devices in ASEAN, USA and EU.
• Experience with product registration submission and evaluation.
• Experience with maintaining internal regulatory database.
• Experience with Dossier Creation.
• Ability to develop and implement plans for regulatory submission.
• Awareness of applicable workplace environment, health and safety regulations.
• Ability to network and build strategic partnership with good problem solving skills and communication skills.
• Possess leadership and agile mindset.

The above eligibility criteria are not exhaustive. A*STAR may include additional selection criteria based on its prevailing recruitment policies. These policies may be amended from time to time without notice. We regret that only shortlisted candidates will be notified.

COMPANY DESCRIPTION

About BW Group

BW Group is a leading global maritime company involved in shipping, floating infrastructure, deepwater oil & gas production, and new sustainable technologies. Founded in 1955 by Sir YK Pao, BW controls a fleet of over 450 vessels transporting oil, gas and dry commodities, with its 200 LNG and LPG ships constituting the largest gas fleet in the world. In the renewables space, the group has investments in solar, wind, batteries, biofuels and water treatment. BW is proud to be listed as one of Forbes World's Best Employers 2023.

Are you ready to make an impact?

What drives us is our mission to deliver energy for the world today, and to find solutions for tomorrow. If you want to make lives better around the world by providing access to energy, while working on sustainability and decarbonisation, we'd like to hear from you. Working at BW you will feel the pulse of the world each day. If something happens in the world, we feel it, and you can play your part by anticipating and responding to it. Our high-performing teams are drawn to BW by the global nature of our work and the satisfaction of working with collaborative people who inspire each other to deliver exceptional results.

RESPONSIBILITIES

We are seeking a highly skilled and experienced IT Compliance and Cyber Risk Manager to join our dynamic IT team. This role is crucial in ensuring our IT operations comply with IT general controls, SOX controls, and other regulatory requirements. Additionally, the manager will lead our Cyber Risk Quantification Program, identifying and mitigating cyber risks to protect our company's assets and reputation.

Responsibilities:

• Compliance Management:
• Ensure all IT operations comply with IT general controls, SOX controls, and other relevant framworks the company chose to company chose to complay with (e.g. NIST CSF, CERT RMM) regulatory requirements.
• Develop, implement, and maintain IT compliance methodology, policies and procedures.
• Work with your IT colleguaes to ensure compliance with internal and external standards. Lead regular assessment with the IT organisation.
• Collaborate with internal and external auditors to facilitate compliance audits and address findings.

• IT-Risk Management:
• Manage the internal Cyber Risk Quantification Program with the company tools to identify, assess, and quantify cyber risks.
• Monitor and report on the effectiveness of IT risk management initiatives.
• Stay updated on the latest IT Risks, cyber threats and vulnerabilities.

• Policy and Procedure Development:
• Develop and maintain IT compliance and cyber risk management policies and procedures.
• Ensure policies and procedures are communicated effectively to all relevant stakeholders.
• Provide training and guidance to IT staff on compliance and risk management best practices.

• Collaboration and Communication:
• Work closely with other departments to ensure a cohesive approach to IT compliance and cyber risk management.
• Communicate effectively with senior management, providing regular updates on compliance status and IT-Risk management activities.
• Serve as the primary point of contact for IT compliance and risk management issues.

• Bachelor's degree in Information Technology, Computer Science, or a related field.
• Minimum of 5 years of experience in IT compliance, ITGC and/or SOX controls, and IT risk management.
• Strong knowledge of IT general controls, Framworks, and regulatory requirements.
• Experience with IT risk quantification and mitigation strategies.
• Excellent analytical, problem-solving, and communication skills.
• Relevant certifications such as CISA, CISSP, CRISC, or similar are highly desirable.
• Strong communication and interpersonal skills, with the ability to effectively engage with stakeholders at all levels.
• Ability to manage multiple tasks and deadlines in a fast-paced environment
• Eager Learner: Has a strong willingness to learn new things and continuously seeks to improve their skills and knowledge.
• Team Player: Works well in a team and contributes to a positive team environment.
• Problem Solver: Demonstrates strong problem-solving skills, with the ability to think critically and find creative solutions to challenges.
• Detail-Oriented: Pays close attention to detail and has a strong commitment to quality.
• Adaptable: Is flexible, can quickly adapt to new situations and changes in project scope or direction, understand the needs of his peers and contribute to a prefessional and enjoyable work environment.

At BW, we offer challenging work in an international environment with a team of dedicated and competent colleagues. We recognise that the success of BW rests with each employee's ability to provide the necessary skills and confidence within the team, and our training is tailored to suit individual needs and career aspirations.

Vision: Best on Water

Mission: We deliver energy for the world today, and find solutions for tomorrow

Values

• Collaborative
• Ambitious
• Reliable
• Enduring

If our values resonate with you and you think you can contribute, we would be delighted to hear from you!

Don't meet every single requirement? At BW, we value diversity and the unique experiences that people from different backgrounds bring to our business. We welcome you to apply for the role even if you don't fully meet all the listed requirements, especially if you are passionate about building an inclusive culture where we strive to be our best. You may be just the right candidate!

Information for Recruitment Agencies:

BW endeavours to recruit and fill vacancies directly. However, when we do need to engage with agencies, BW operates a preferred supplier list (PSL) and will not be accepting unsolicited applications from non-PSL agencies for this role.

Responsibilities:

• Manage the implementation of Reckitt Quality Systems to support business strategies by ensure compliance to Reckitt Quality Manual and applicable local regulatory requirements.
• Assess, communicate, and implement policies, procedures and initiatives from Global / Regional Quality.
• Increase Quality mindset of the site organization by leading Quality awareness enhancement programs, such as Quality Month Awareness etc.
• Monitor and share site functions’ Key Quality performance indicators and identify continuous improvement opportunities that lead to a higher performing quality culture.
• Lead site Change Control Management to comply with Global Quality System requirement and verify the effectiveness of approved change requests. Liaise with Global / Regional Change Control community as required.
• Manage document control system for use by functions within the Singapore Supply Centre site. Review and approve local SOP in the PDMS (Procedural Documentation Management System) to ensure they met Reckitt quality system requirements, and have incorporated relevant new learning / processes and regulatory changes.
• Ensure timely review of materials and products quality and perform disposition to meet production schedule and delivery deadlines.
• Coordinate and facilitate non-conformance (NC) investigations, and ensure that root-cause analysis by the investigation team is thorough and complete, and appropriate corrective and preventive actions (CAPA) are put in place to minimize product loss.
• Prepare Potential Early Quality Alert (EQA) when required, and follow-up on sharing of key learning.
• Support food safety /HACCP team for HACCP 2.0 & other food safety requirement eg. Contaminant, Food fraud etc.
• Implement an effective internal audit program and ensure compliance to requirements of: GMP / HACCP pre-requisite programs, Quality systems, Halal assurance system.
• Lead site team to prepare for audits (e.g. Global/Regional Quality Audit, External Certification Bodies), and ensure agreed audit findings are corrected and preventive measures are put in place.
• Organize Annual Product Review to drive product quality improvement.
• Support innovation projects and timely launch of new production introduction.
• Manage the customer complaint handling system – evaluation, investigation and corrective/preventive action planning, implementation and monitoring.
• Manage the local Mock Recall exercise as per Reckitt procedures.
• Assist Senior Manager, Quality in liaison with Global / Regional Quality in crisis situations, such as a potential product recall, or high-profile customer complaint.
• Represent the Singapore Supply Centre in various quality professional communities (e.g. GMC) to create a network for teaching and learning and identification of best practices.
• Support OE/Engineering improvement projects to ensure compliance to Reckitt quality systems requirements.
• Support Procurement team to help existing material suppliers to meet Reckitt Quality standards through sharing / training. Support the RMAQ (Raw material attribute questionnaire) review process for new material suppliers.
• Develop succession and development plans for direct reports, ensuring for their career growth and succession.
• Perform other tasks, roles or projects that may be assigned by the Plant Director or Senior Manager, Quality from time to time.

Requirements:

• Bachelor degree in a scientific or technical discipline (Chemistry, Microbiology, Food Science or related)
• 5 years of Quality Assurance / Quality Systems in a regulated food manufacturing industry. Experience in manufacturing of infant/follow up formula will be of advantage.
• Performed supervisory role for min 3 years.
• Experienced in establishing/implementing Quality Management Systems, Food Safety Management System, Halal Assurance System.
• Preferably with extensive quality system audit experience.
• Experienced in collaborating with various functional roles within the organization to develop strategies and execute action plans to resolve critical issues.
• Strong understanding and working level knowledge of quality systems including HACCP, change control, corrective action/preventive action, process/product qualification, and the successful application of these strategies across an organization to produced desired results.

· Maintain full sets of accounts 8 small Companies

· To ensure the efficient and effective running of the GL, AR, AP, PPE and cash accounting functions of the Company.

· To ensure timely month-end and year-end closing and reporting of the Company accounts in accordance with GAAP and the Stamford Tyres Group accounting policy.

· To ensure timely month-end and year-end MSOR reporting per Management's requirement (both at HQ and locally).

· To manage the audit, tax, corporate and legal processes of the Group in order to maintain and ensure compliance with all applicable laws and regulations, particularly GST, Customs, FBT and labour laws.

· To be responsible for the payroll and human resource functions of the Company – including salary disbursements, staff benefits administration, health insurance coverage, work permit applications, etc.

· To prepare annual budget and cash flow forecasts for management reporting purposes.

· To be responsible for the internal controls over the assets of the Company – particularly inventory, accounts receivables and cash per Group Standard Operating Procedures (SOP).

· To review and manage the adequacy of insurance coverage process together with the Head of Operations to ensure the Company's assets, liabilities and contingencies are adequately covered at all times.

Ad-hoc duties assigned (eg transfer pricing policy drafting, accounting manual drafting, etc).

Job Description & Responsibilities

• Maintenance of Quality Management System ensuring compliance to internal, and international standards and regulatory requirements for medical devices.
• Develop QMS documents in line with business activity of DxD Hub.
• Ensure the overall document control system supports the QMS.
• Work with technical team to create quality document related to product design, development, and manufacturing, including product test/validation protocols, change management in compliance to applicable regulatory requirements.
• Lead auditor for internal and external audits.
• Conduct management review, ensure QMS stays current and relevant.
• Lead in root cause analysis and CAPA.
• Analyze trends inquality performance.
• Drive improvement in the quality management system.

Job Qualifications

• At least a Bachelor’s degree in Science/Engineering or relevant related field.
• Possess at least 4 years of working experience in quality assurance in medical devices; thorough working knowledge of ISO 13485:2016.
• Good working knowledge in managing QMS in a medical device environment in compliance to ISO 13485:2016.
• Competent in quality assurance methodologies.
• Working knowledge in QA processes for design, development, and manufacturing of IVD, SaMD and Integrated Medical Technologies.
• Demonstrated skills in risk management (ISO 14971).
• Knowledge in regulatory requirements for medical devices in ASEAN, USA and EU.
• Strong background in biomedical, computer or engineering sciences.
• Awareness of applicable workplace environment, health, and safety regulations.
• Possess creative skills and problem-solving skills.
• Adeptness in cultivating professional networks and build strategic partnerships.
• Good communication skills.
• Demonstrates strong leadership capabilities and an agile mindset.

The above eligibility criteria are not exhaustive. A*STAR may include additional selection criteria based on its prevailing recruitment policies. These policies may be amended from time to time without notice. We regret that only shortlisted candidates will be notified.

Job Description & Responsibilities

• Maintenance of Quality Management System ensuring compliance to internal, and international standards and regulatory requirements for medical devices.
• Develop QMS documents in line with business activity of DxD Hub.
• Ensure the overall document control system supports the QMS.
• Work with technical team to create quality document related to product design, development, and manufacturing, including product test/validation protocols, change management in compliance to applicable regulatory requirements.
• Lead auditor for internal and external audits.
• Conduct management review, ensure QMS stays current and relevant.
• Lead in root cause analysis and CAPA.
• Analyze trends inquality performance.
• Drive improvement in the quality management system.

Job Qualifications

• At least a Master's degree in Science/Engineering or relevant related field.
• Possess at least 4 years of working experience in quality assurance in medical devices; thorough working knowledge of ISO 13485:2016.
• Good working knowledge in managing QMS in a medical device environment in compliance to ISO 13485:2016.
• Competent in quality assurance methodologies.
• Working knowledge in QA processes for design, development, and manufacturing of IVD, SaMD and Integrated Medical Technologies.
• Demonstrated skills in risk management (ISO 14971).
• Knowledge in regulatory requirements for medical devices in ASEAN, USA and EU.
• Strong background in biomedical, computer or engineering sciences.
• Awareness of applicable workplace environment, health, and safety regulations.
• Possess creative skills and problem-solving skills.
• Adeptness in cultivating professional networks and build strategic partnerships.
• Good communication skills.
• Demonstrates strong leadership capabilities and an agile mindset.

The above eligibility criteria are not exhaustive. A*STAR may include additional selection criteria based on its prevailing recruitment policies. These policies may be amended from time to time without notice. We regret that only shortlisted candidates will be notified.

Job Description:

• Drive PGCS Quality programs and policies compliance across site, by partnership with functional stakeholders.
• Key contributor/promoter to the advancement of Quality function across the sites; creating and driving critical/key business objectives in line with supporting/partnering with Operations, Supply Chain functions etc.
• Lead incident management and resolution and champion customer quality across Singapore. Site lead for Quality and Food safety crisis mgmt.
• Lead the implementation of the Singapore Quality Strategy including communication, project management and roll out activities.
• Lead continuous improvement culture/productivity initiatives to support site BPI process, demonstrating best practices to implement all quality improvements
• Drive, support and champion KPIs, key Quality metrics, etc.
• Act as a business partner to other functions whilst championing Quality, to ensure an extended and consistent quality focus.
• Be a key member of the Site Leadership team and value add in driving functional and site agenda.
• Support and provide strategic guidance around NPIs, validation, Total Quality System, Compliance, Capital investment, etc.
• Partnership with other functions ensuring change control risk assessment and validation in place for Network capacity projects and other key projects and significant changes.
• Financial Management; Budgetary and AOP responsibilities/input.
• Compliance; drive partnership with other functions through the Quality team to achieve key business goals for the control environment. Compliance with all regulations and 3rd party auditing requirements.
• Provide strategic quality leadership to the extended Quality Team
• Organisation design & sustainability of a highly effective team with appropriate succession plan. Encourage, manage & promote people-related activities/processes, partnering with HR
• Develop capability, personal growth and career development for direct reports, support these activities with DRs’ associated teams.
• Play in instrumental role in developing the overall team capability, supporting and aligning with overall plant culture.
• Ensure the smooth transition of new products to the Singapore facilities.
• Manage the complexity of additional materials, packaging and concentrate components from a quality perspective as portfolio expands
• Support and implement PGCSSC global quality initiatives
• Systems improvements (including IT systems) in terms of Processing, GMP, Product Safety, Disposition and Traceability.
• A requirement of the role is that you must adhere to all PepsiCo Health & Safety requirements.

Qualifications :

• Bachelor’s Degree in Science, Food Technology, Chemistry or any other related discipline
• Minimum 7 years of relevant experience as a supervisor in operating Laboratory environment, manufacturing concern/MNC
• Ability to manage senior stakeholders and leadership team members
• Experience in People Management and prior supervisory skill
• Possess knowledge of and experience in GLP, HPLC / GC operation, SAP QM module and LIMS management
• Strong leadership presence, ability to manage and co-ordinate with cross-functional teams on investigation analysis, troubleshooting and issues resolution
• Knowledge of food safety quality standards such as HACCP and FSSC 22000
• Ability to lead change and drive behaviours
• Ability to organize and manage multiple priorities in high-pressure work environment
• Strong collaboration and influencing skills
• Excellent communication and interpersonal skills, both verbal and written with ability to clearly articulate ideas and proposals to all levels of the organization
• Positive and Can-do Attitude
• Willing to stretch and take additional responsibilities when needed
• Lead by example to others

Kindly note that this is a short-term role based in Singapore.

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Did you know that we are the 1st biologics contract manufacturer in Singapore? We offer you exposure to upcoming biotech and established pharmaceutical companies and to the manufacturing technology needed to produce mammalian treatments and cell therapies of tomorrow. Our global manufacturing network is recognized for its reliable, high-quality services, regulatory track record, global footprint, innovative technology platforms and extensive experience – we, in Singapore are proud to be part of this global network.

This is an exciting position who is responsible for QA oversight of Aseptic Processing Program, Environmental Monitoring and Microbial Control Policies for the Cell and Gene Therapy entity. Role will provide oversight and sterility assurance expertise to Operations to assure aseptic processing meets US and international aseptic processing requirements ( FDA Sterile Product Aseptic Processing Guidance and Eudralex, Annex 1,” Sterile Medicinal Drug Products”, ISO 13408 and 21CFR820).

The role will also provide strategic plan and expertise for the development and implementation of the Microbial Control Strategy. Develop, document and manage microbial control strategy for production processes from incoming raw materials through final product release.

Key responsibilities:

• Provide support and expertise to ensure that Cell and Gene Therapy (CGT) and Media preparation operations and support functions for Cleanroom management, Materials Management, Aseptic practices, Environmental monitoring (EM). Sterilisation methods, and Aseptic process simulations (APS) to confidently deliver CT products to patients with the highest quality sterility assurance level.
• Review policies and procedures and related completed media fill/APS documentation, Environmental Monitoring sample plans, cleanroom qualifications, environmental monitoring excursions, deviations and sterility failures.
• Provide Sterility assurance expertise to support APS/EM deviations and investigations, CAPAs and Complaints related to aseptic processing.
• Review of sterile filter validations, integrity testing and procedures.
• Provide expert support and assessment to business partners including production, MSAT, Engineering, QC and QA assuring adequate facilities contamination prevention practices, monitoring tools are provided to production to guarantee the best EM indicator levels.
• Involvement in global harmonization/ efficiency projects; begin to lead aspects of global projects within specific areas.
• Represent site in global forums from sterility assurance perspective. Collaborate with stakeholders of different functions to lead/implement various global/site projects to support sterility assurance.
• Support regulatory and client audits as Aseptic sterility assurance subject matter expert
• Responsible for the generation of key performance indicators, GEMBA walks, regulatory compliance and efficiency targets.
• Communicate quality operations and compliance perspective effectively to senior management.
• Understand and articulate company business strategy. Maintains a broad view of the business recognizes changes and trends in the appropriate area in which the individual operates.

Key requirements:

• Engineering/ Life Science Diploma/Degree or higher from recognized institution with significant years of QA or QC Sterile processing and Microbial experience in similar capacity.
• GMP experience in the biologics industry is required.
• Working knowledge of microbiological and sterility testing, media fills, environmental monitoring , clean room qualification and management, quality control endotoxin testing and microbiological control strategy required.
• Experience with oversight of aseptic processing and the associated international aseptic processing regulations are required.
• Experience in cell culture, cell or gene therapy experience is a plus.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

R63423

Project Description:Our Customer is a Leading bank in Asia that provides a front to back integrated platform for straight through processing and risk management.
This is a multi-year initiative where different projects run in concurrence under the program's variety milestones. These streams include new product initiatives, new entity roll-outs and regulatory compliances.
We will have key roles in projects such as managing the scope, design and delivering requirements from front to back office with Luxoft.

Responsibilities:

• Define the testing strategy and framework to ensure a high standard of testing and quality assurance is in place
• Plan and manage various phases of testing (SIT, UFT, UAT & Regression)
• Manage the test preparation, test cycles & test environment
• Engage test automation team for planning, scripting and execution of test scripts
• Chair the test progress meeting
• Conduct defect triage meetings with Vendor, Users and IT teams
• Plan and manage the runbook for all testing phases, Mock Runs & Production Implementations
• Report test progress and Issues (Daily, Weekly)
• Provide metrics and status updates for organization reporting
• Work with different IT teams across infrastructure and various business divisions to deliver testing solutions for the business.
• Be the focal point of contact for Business testing needs
• Liaise with technical lead / Project managers to manage expectations for each of the testing stages of projects. Agree 'quality gate' criteria and corrective actions
• Stakeholder management
• Adhere to the Bank's Service Management guidelines (ITIL) and participate and provide recommendations in process, service and system improvements

Mandatory Skills Description:

• 8+ years of software testing experience
• Minimum 4 years of experience as Test Manager on Murex platform
• Knowledge on financial market products
• Understanding of bank's front, middle and back office operations, finance and accounting. Experience and management of at least one Front to Back implementation within a financial services organization
• Experience in vendor management and good IT risk understanding.
• Understanding of Murex automation using GUI tools such as QTP as well as Report comparison tools.
• Experience on murex setup and functional tests using various module of murex.
• Ability to work independently and take decisions
• Experience in working direct with Technical leads, project managers and Business Analysts in business and IT organization
• Experience with Principles, methods, techniques and tools for the effective management of the testing process
• Experience of the execution of tests throughout the lifecycle of development projects
• Excellent communication, inter-personal skills and problem solving skills

Nice-to-Have Skills Description:

• MxTest experience

Job Overview:

The QA Manager will be responsible for managing and overseeing all quality assurance activities within the organization, ensuring that products and services meet all quality standards. The ideal candidate will have in-depth knowledge of Quality Management Systems (QMS) and ISO certification processes, driving continuous improvement and compliance across the organization. This role plays a critical part in ensuring the company meets regulatory and customer expectations.

Key Responsibilities:

• Quality Management System (QMS):Develop, implement, and maintain the Quality Management System (QMS) in alignment with ISO standards (e.g., ISO 9001, ISO 14001, etc.).
  Regularly audit and review QMS processes to ensure continuous improvement and compliance.
  Ensure documentation, procedures, and processes align with QMS requirements.
  
• ISO Certification Management:Lead and manage the ISO certification process, including initial certification, recertification, and internal audits.
  Coordinate with external certification bodies and manage relationships to ensure the company's certification status is maintained.
  Provide guidance and training to staff regarding ISO requirements and their roles in maintaining certification.
  
• Quality Assurance Oversight:Oversee all quality assurance operations, including quality control procedures, testing protocols, and defect management.
  Implement and enforce QA standards and policies throughout the production and service delivery processes.
  Collaborate with cross-functional teams (production, engineering, procurement, etc.) to ensure product quality.
  
• Internal Audits & Continuous Improvement:Plan and conduct internal quality audits, identifying non-conformance and areas for improvement.
  Lead root cause analysis for quality-related issues and implement corrective and preventive actions (CAPA).
  Promote a culture of continuous improvement by developing and executing process optimization initiatives.
  
• Compliance & Risk Management:Ensure company compliance with applicable regulatory requirements, industry standards, and customer expectations.
  Identify and mitigate risks associated with product quality and process inefficiencies.
  Maintain an up-to-date understanding of changes in quality regulations and standards relevant to the industry.
  
• Team Leadership & Development:Manage and mentor the QA team, fostering a culture of accountability, professional development, and continuous improvement.
  Provide leadership in solving complex quality issues, both internally and with external stakeholders.
  
• Customer & Supplier Interface:Act as the primary point of contact for quality-related concerns from customers and suppliers.
  Ensure effective communication of quality standards and expectations to suppliers and collaborate to resolve quality issues.
  

Qualifications and Skills:

• Education:Bachelor’s degree in Engineering, Quality Management, or a related field.
  Advanced degrees or certifications in Quality Assurance or Management (preferred).
  
• Experience:Minimum of 8-10 years of experience in quality assurance, with at least 3-5 years in a management role.
  Proven experience in managing QMS and ISO certification processes in manufacturing, engineering, or production environments.
  
• Technical Skills:In-depth knowledge of ISO standards, especially ISO 9001 (Quality Management), ISO 14001 (Environmental Management), or related certifications.
  Proficiency in quality assurance methodologies such as Six Sigma, Lean, FMEA, and root cause analysis.
  Strong experience in conducting audits and leading CAPA processes.
  
• Soft Skills:Excellent leadership, communication, and team management abilities.
  Analytical mindset with problem-solving skills and attention to detail.
  Ability to work cross-functionally and manage multiple projects simultaneously.
  

The Regional Trade Compliance Manager is responsible for ensuring the import or export of products and materials complies with the regulations within a region. This includes assisting in the deployment of regional and/or localized trade compliance procedures and guidelines that will assure compliance with import and export regulations, executing audit and risk assessment programs including corrective action plans and providing leadership in strategic projects that affect the supply chain to ensure proper/advantageous structuring of transactions. In addition to developing and ensuring process adherence, the role will act as a key knowledge point for all trade compliance issues and take a lead in the training and development of key stakeholders.

How You’ll Make an Impact:

• Maintains and evaluates the region’s compliance status with various regulatory bodies including customs, export control and applicable tax authorities. Ensuring proper documentation and procedures are maintained in accordance with regulations.
• Reviews internal controls, develops processes, administers the compliance audit program, and oversees corrective action plans for the region. Identifies compliance gaps and recommends process improvements.
• Assists in establishing and maintaining localized policies and procedures for compliance with import and export regulations as well as ensuring broad Company awareness of these requirements.
• Identifies and develops business processes to address compliance risks, with a focus on continuous process improvements to increase efficiency and improve performance to customers.
• Responsible for monitoring and reporting KPIs and metrics to senior management and daily reporting of import and export compliance for the region.
• Sets overall budget, operational strategy and priorities for assigned area of responsibility.
• Prioritizes and manages projects in the region for both import and export compliance which involves defining the project scope, budget, scheduling and execution of project risk.

What You Bring:

• Bachelor’s or advanced degree in International Business, Business Administration or Supply Chain management.
• Customs broker license.
• At least 10 years trade compliance experience, with minimum 5 years' of management experience and trade compliance for multiple countries or in a global environment.
• Expert working knowledge of import and export regulations across the region, including Import Licensing, Export Licensing, Free Trade Agreements, HTS and Export Control Classification, Country of Origin, Valuation, Transfer Pricing, Authorized Economic Operator, Customs Trade Partnership Against Terrorism, Approved Exporter.
• Knowledge and ability to handle other Government Agency requirements applicable to Bio-Rad products, such as, but not limited to health registration agencies, veterinary controls and other related Export and Impart regulations within the region and countries.
• Experience with global trade management software and systems, and with implementation and scaling of trade automation tools including but not limited to SAP-GTS.
• Experience writing and submitting binding rulings and a proven record of designing and implementing value added import/export policies and processes.
• Experience with audits and disclosure practices.
• Experience working in the Medical Device, Pharmaceutical, Life Sciences or Diagnostic industry highly preferred.
• Demonstrated strong leadership, communication, analytical and people management skills.
• Exceptional verbal and written communication skills and interpersonal skills at all levels in the organization.
• Results orientation and strong sense of accountability.

Who We Are: For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives. Recently voted a Best Place to Work, Bio-Rad offers a unique employee experience with collaborative teams that span the globe. Here, you are supported by leadership to build your career and are empowered to drive change that makes an impact you can see.

Benefits: Bio-Rad's biggest asset is our people, and this is the reason why our Total Rewards deliver programs that provide value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. Our offerings serve to enrich the overall health, wealth, and wellbeing of our employees and their families through the various stages of an employee’s work and life cycle. We’re proud to offer comprehensive medical plans and insurance, wellness programs, extensive learning and development opportunities and more.

EEO Statement: Bio-Rad is an Equal Employment Opportunity/Affirmative Action employer, and we welcome candidates of all backgrounds. Veterans, people with disabilities, and people of all races, ethnicities, genders, ages, and orientations are encouraged to apply.

Agency Non-Solicitation: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.

Responsibilities:

• Manage daily QA duties and the QA/testing team.
• Develop and implement quality practices in methodologies and processes.
• Manage/support multiple QA projects.
• Develop QA plan and timeline.Recommend improvement to processes and practices to IT management and application team.

Note: Proceeding to apply on this job post means you have read, understand and agreed to WPH DATA PROTECTION NOTICE FOR JOB APPLICANTS in the link below.

https://www.wphdigital.com/notices