Total 140 Manager level Quality Assurance / Control job vacancies in Fortress Hill, Hong Kong Island

Job Description:

• Building & Demolition projects

• Restoration and Refurbishment Works

• Additions and Alteration Works

• Driving IDD implementation for the works

Job Requirements:

• Degree in Architecture, Civil & Structural Engineering, Mechanical & Electrical Engineering, Building Science or Quantity Surveying from a University recognized by the respective Professional Bodies or Professional Institutions.

• Minimum 5 years of practical experience in the design and/or construction management of construction projects with contract value of $5 million and above.

Job Description:

• Infrastructure works like roads, drains, sewer works and ancillary works;

• Rectification of infrastructure works such as roads, drains, sewers and ancillary works for handing over to authorities;

• Provision of amenities such as footpaths/pavements, Personal Mobility Device (PMD) tracks, cycling paths, sheltered linkways, decking, etc;

• Construction of surface parking for cars, buses, heavy vehicles;

• Road traffic and junction improvements such as installation of road signage, lane markings;

• Construction of bus stops, bus bays, pedestrian overhead bridges and associated works;

• Earthworks and disposal of debris, removal of stockpiles and other unusable material;

• Slope protection and rectification, Trial trench works;

• Minor land clearances and clearing of overgrown vegetation;

• Instrumentation & Monitoring

Job Requirements:

• Degree in Civil & Structural Engineering from a University recognized by the Professional Engineers Board (PEB) and/or accreditation recognized by the Professional Engineers Board.

• At least 5 years of practical experience in the management of building (e.g. new building, R&R and A&A projects) or infrastructure (e.g. road, drain, sewers, services diversion) projects with contract value of $5 million and above.

• The PM must be familiar with PSSCOC.

• At least 2 years of relevant working experience or involvement in Integrated Digital Delivery (IDD) for project delivery and built environment industry.

• Strong, mature and proven ability to organize, manage and motivate a project team.

Job Description:

• Infrastructure works like roads, drains, sewer works and ancillary works;

• Rectification of infrastructure works such as roads, drains, sewers and ancillary works for handing over to authorities;

• Provision of amenities such as footpaths/pavements, Personal Mobility Device (PMD) tracks, cycling paths, sheltered linkways, decking, etc;

• Construction of surface parking for cars, buses, heavy vehicles;

• Road traffic and junction improvements such as installation of road signage, lane markings;

• Construction of bus stops, bus bays, pedestrian overhead bridges and associated works;

• Earthworks and disposal of debris, removal of stockpiles and other unusable material;

• Slope protection and rectification, Trial trench works;

• Minor land clearances and clearing of overgrown vegetation;

• Instrumentation & Monitoring

Job Requirements:

• Degree in Civil & Structural Engineering from a University recognized by the Professional Engineers Board (PEB) and/or accreditation recognized by the Professional Engineers Board.

• At least 5 years of practical experience in the management of building (e.g. new building, R&R and A&A projects) or infrastructure (e.g. road, drain, sewers, services diversion) projects with contract value of $5 million and above.

• The PM must be familiar with PSSCOC.

• At least 2 years of relevant working experience or involvement in Integrated Digital Delivery (IDD) for project delivery and built environment industry.

• Strong, mature and proven ability to organize, manage and motivate a project team.

Job Description:

• Develop & implement Project Quality Plan, all QA/QC inspection and testing, as required by contract specifications and by regulatory requirements;
• Lead and manage the QA/QC team in the various disciplines including but not limited to qualified welding and fabrication inspection.
• Oversee preparation of Welding Procedure Specification, Welder Qualification Record and Quality Procedures;
• Ensure compliance to the overall Quality Management System, policies and standards
• Develop and implement preventive measure and corrective actions for non-conforming products include training to ensure awareness of quality procedures and specific responsibilities in the QA/QC process.
• Able to audit QA/QC activities of the staff and sub-contractors to assess conformance with the QA/QC procedures.
• Liaise and attend with consultants and subcontractors for QAQC activities
• Carry out inspections to in-progress / completed works and ensure Works are in accordance to project specification.
• Raise report of any non-conformances and carry out root cause analysis.
• Monitor corrective actions and process improvement.
• Manage subcontractors to clear defects
• Document QAQC records and prepare handover documents.

Requirements:

• Degree in Mechanical Engineering or equivalent
• Minimum 8 years of relevant experience in the setting up, day to day management, testing and inspecting, auditing and reporting of all aspects of the QA/QC of similar major projects in the waste, oil and gas, water or petrochem industries.
• Good Organizational and planning skill.

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.

The incumbent is responsible for managing the company's freight operations, ensuring that goods are transported efficiently, cost-effectively, and in compliance with regulatory requirements. This role involves coordinating with carriers, negotiating contracts, and overseeing the logistics team to streamline freight processes and improve overall supply chain performance.

JOB RESPONSIBILITIES:

1. Operational Management:

• Plan, organize, and oversee the daily operations of freight management.
• Monitor and manage the performance of carriers and freight service providers.
• Through the used on AI and pre-alert tool, proactively response to shipments to prevent disruption

2. Compliance and Documentation:

• Ensure compliance with national and international shipping regulations and standards.
• Prepare and review shipping documents, including bills of lading, customs documentation, and other required paperwork.
• Handle any legal or regulatory issues related to freight transportation.

3. Customer Service:

• Address and resolve freight-related issues and inquiries from customers, ensuring high levels of satisfaction.
• Work with other departments to manage delivery exceptions and provide timely updates to customers.

4. Reporting and Analysis:

• Prepare regular reports on freight performance, including cost analysis, delivery metrics, and other key performance indicators (KPIs).
• Analyze data to identify trends, areas for improvement, and potential risks.
• Make recommendations for process improvements based on analysis.

5. Technology and Systems:

• Utilize freight management software and other technologies to streamline operations and improve efficiency.
• Stay updated on industry trends and advancements in technology.

JOB REQUIREMENTS

1. Bachelor's degree or equivalent in logistics, supply chain management, business administration, international trade or a related field.
2. Minimum of 5 years of experience in freight operations or logistics management.
3. Experience in trade compliance, customs knowledge in the region
4. Strong experience in trade compliance and customs knowledge, with an in-depth understanding of international trade laws and regulations.
5. Proven ability to conduct risk assessments and implement effective mitigation strategies.
6. Excellent analytical skills to interpret complex regulations and situations.
7. Knowledge of regional freight processes and documentation.
8. Strong analytical skills to interpret complex regulations situation
9. Willingness and ability to travel on short notice as required.

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.

Job Description:

DATA PROTECTION
Roles & Responsibilities
1. Serve as the main/first point of contact between the Group and all relevant data protection authorities/ regulators.
2. Ensure the Group’s policy is in line with the General Data Protection Regulation (GDPR) and code of practice.
3. Evaluate, review and enhance the existing framework, ensuring its relevance with the Group’s businesses in consultation with key stakeholders.
4. Proactively conduct regular internal security audits to ensure compliance, address potential issues and submit monthly reports for management’s review.
5. Provide guidance, and support, and act as the subject matter expert to Management and fellow colleagues.
6. Conceptualise, and translate ideas and regulations into an effective training package; train and conduct workshops for internal staff members.
7. Train and guide members of staff involved in processing data on all the key salient points for compliance.
8. Follow up with changes in law and provide suggestions to ensure compliance with GDPR.
9. Foster a data protection culture amongst employees and communicate personal data protection policies to stakeholders.
10. Manage personal data protection-related queries and complaints.
11. Alert management of any risks that might arise with regard to personal data management.
12. Liaise with PDPC on data protection matters.

OTHER RISK AND COMPLIANCE DUTIES
1. Creating and implementing an effective compliance program, statutory and operationally
2. Ensuring that the compliance program effectively prevents and/or detects violations of law, regulations, organization policies, or the code of conduct
3. Regularly reviewing the compliance program and recommending appropriate revisions and modifications, including advising the Senior Management of potential compliance risk areas
4. Conducting yearly compliance refresher training
5. Process owner for the following policies:
a. Anti-bribery policy
b. Gifts and hospitality
c. Whistleblowing policy
6. To spearhead the implementation of Enterprise Risk Management and maintain the risk register for the Group

Job Requirement:
1. Minimum degree from accredited universities with 5 years of relevant experience
2. Critical and strategic thinking, ability to provide sound judgements in challenging situations and be assertive as needed.
3. Experience in legal, audit, and/or risk management roles will be an added advantage.
4. Good interpersonal skills and ability to work independently, objectively, and constructively.
5. Strong interpersonal, negotiation, organisational and report-writing skills.
6. Team player with project management skills.
7. Excellent communication and presentation skills.
8. Ability to work under pressure, hands-on experience in audit, investigation, training, policy development and process improvement.

The incumbent is responsible for managing the company's freight operations, ensuring that goods are transported efficiently, cost-effectively, and in compliance with regulatory requirements. This role involves coordinating with carriers, negotiating contracts, and overseeing the logistics team to streamline freight processes and improve overall supply chain performance.

JOB RESPONSIBILITIES:

1. Operational Management:

• Plan, organize, and oversee the daily operations of freight management.
• Monitor and manage the performance of carriers and freight service providers.
• Through the used on AI and pre-alert tool, proactively response to shipments to prevent disruption

2. Compliance and Documentation:

• Ensure compliance with national and international shipping regulations and standards.
• Prepare and review shipping documents, including bills of lading, customs documentation, and other required paperwork.
• Handle any legal or regulatory issues related to freight transportation.

3. Customer Service:

• Address and resolve freight-related issues and inquiries from customers, ensuring high levels of satisfaction.
• Work with other departments to manage delivery exceptions and provide timely updates to customers.

4. Reporting and Analysis:

• Prepare regular reports on freight performance, including cost analysis, delivery metrics, and other key performance indicators (KPIs).
• Analyze data to identify trends, areas for improvement, and potential risks.
• Make recommendations for process improvements based on analysis.

5. Technology and Systems:

• Utilize freight management software and other technologies to streamline operations and improve efficiency.
• Stay updated on industry trends and advancements in technology.

JOB REQUIREMENTS

1. Bachelor's degree or equivalent in logistics, supply chain management, business administration, international trade or a related field.
2. Minimum of 5 years of experience in freight operations or logistics management.
3. Experience in trade compliance, customs knowledge in the region
4. Strong experience in trade compliance and customs knowledge, with an in-depth understanding of international trade laws and regulations.
5. Proven ability to conduct risk assessments and implement effective mitigation strategies.
6. Excellent analytical skills to interpret complex regulations and situations.
7. Knowledge of regional freight processes and documentation.
8. Strong analytical skills to interpret complex regulations situation
9. Willingness and ability to travel on short notice as required.

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