Total 149 Manager level Quality Assurance / Control job vacancies in Central, Hong Kong Island

The successful candidate will handle, manage, and oversee corporate secretarial matters of TracX Logis Pte. Ltd and its group companies and provide general commercial legal support operating in the APJ region.

Duties and Responsibilities

Corporate Secretarial Support & Compliance

• To support all the Board requirements including preparing directors' resolution and other corporate secretarial related documents as required to support the Company and its group companies' needs and requirements by drafting and/or facilitating execution of corporate documents/resolution.
• To liaise with local corporate secretarial service providers, external legal counsel on corporate secretarial and compliance related matters with specific focus on statutory filings.
• To maintain, update and safekeep records of constitutional documents, Statutory Registers, minutes and resolutions.
• To handle KYC and other corporate secretariat related queries from internal and external stakeholders.
• To ensure compliance with all relevant legislation / regulations by assisting in creating and implementing internal policies that promote legal compliance and best practices.

General Commercial Legal Support

• To provide precise and timely legal counsel on a wide range of legal, contractual, and procurement matters.
• To manage and oversee the administration of legal contracts.
• To work closely with senior management and other teams to offer legal insights and support strategic business decisions.

Job Requirements:

• Minimum 3 years PQE or relevant working experience, in-house experience in a multi-national company is preferred.
• Non-legal professionals with minimum 5 years’ corporate secretarial experience with relevant qualifications will be considered.
• Strong command in English and excellent writing skill.
• Organised and able to manage deadlines and work with tight deadlines.

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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.

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.

Job Responsibilities :

The Global Head of Ethics and Compliance will lead the Ethics and Compliance function in developing and enhancing compliance and regulatory policies and practices Razer businesses worldwide. This Senior Director-level role will report to the Chief Corporate Officer and work closely with the Legal team and operational compliance leaders in the various business units to ensure adherence to all applicable laws, regulations, and ethical standards.

• Serve as Ethics and Compliance partner to business units and other functions providing relevant advice to the rest of Razer.
• Build the Global Ethics and Compliance team and create visibility and awareness of the Ethics and Compliance practice across the organization, in adherence to legal and regulatory requirements, as well as Razer’s ethical standards.
• Design and build Ethics and Compliance policies and procedures relating to various aspects of our operations including trade compliance, product compliance and anti-bribery/ corruption.
• Collaborate with internal stakeholders such as Legal, HR, Internal Audit, Supply Chain Management, Razer Gold Compliance, FIUU Compliance, Information Security, Sustainability and Engineering to integrate compliance and ethics into daily operations and decision-making processes.
• Lead, conduct, and manage investigations, inspections, and audits as required.
• Lead discussions with regulators and other third parties and serve as Razer’s representative with external bodies.
• Develop and deliver training programs to promote a culture of ethics and compliance across the organization.
• Stay abreast of industry trends and best practices in ethics and compliance to continually improve Razer’s ethics and compliance program.

Pre-Requisites :

• A recognized degree in Law, Accountancy, Business Management, Finance, or equivalent.
• Minimum 15 years’ experience in a similar compliance or regulatory role covering various compliance areas such as personal data protection, anti-bribery, trade sanctions, and ethics and conduct.
• Relevant experience working for an MNC in consumer electronics or manufacturing.
• Knowledge and familiarity with the laws and regulations in key jurisdictions such as USA, PRC and EU.
• Experience in managing compliance processes and procedures such as management of bribery or sanctions red flags, vendor risk management.
• Able to lead the development and roll-out of compliance training programs across different jurisdictions and offices.
• Candidate must have the inclination to quickly develop an acute understanding of the Razer business and be determined to grow and develop the function and team.

Primary Purpose

Reporting to the Senior Manager, Supply Chain SMO/COE, the Master Data Quality & Governance Manager plays a vital role in ensuring the accuracy and integrity of master data and will be responsible for overseeing and implementing data governance strategies, policies, practices, and processes across the Asia Pacific region. This role is also responsible for collaborating with APAC business stakeholders to understand their data needs and requirements and ensuring data quality standards, processes and procedures align with business objectives, and providing training and support to business stakeholders on data quality best practices.

Develop and Implement Data Governance Framework:

o Design and establish a comprehensive data governance framework across the Asia Pacific region.

o In partnership with Global Data Governance teams define data governance policies, procedures, and standards to ensure consistent and accurate data management practices.

o Collaborate with stakeholders to gain buy-in and support for the data governance initiatives.

Data Stewardship and Ownership:

o Establish data quality rules, monitor data compliance, and resolve data-related issues.

o Ensure data ownership and accountability by establishing data governance and execution roles and responsibilities.

o Drive continuous improvement by monitoring data governance performance and identifying opportunities for enhancement.

o Conduct regular data audits and assessments to identify gaps and recommend corrective actions.

o Collaborate with cross-functional teams, including IT, finance, operations, privacy and legal to ensure alignment and compliance with data governance initiatives.

o Engage with global stakeholders to share best practices, leverage synergies, and contribute to the overall data governance strategy.

Training and Awareness:

o Develop training programs and materials to educate employees on data governance policies, procedures, and best practices.

o Raise awareness of the importance of data governance and its impact on business operations and decision-making.

o Provide guidance and support to business units in implementing data governance practices effectively.

o Act as a subject matter expert, providing guidance and support to stakeholders on data governance-related matters.

Inherent Requirements

Formal Qualifications

Bachelor's in information management, computer science, business administration, or a related field.

Key Skills / Core Competencies

• Strategic thinking ability, as well as detailed analytical and problem-solving skills
• Strong communication and relationship building skills to collaborate cross functionally with internal partners and external customers.
• Comfort in managing relationships with senior leadership.
• Strong entrepreneurial, customer service orientation.
• Ability to effectively prioritize, execute tasks and manage deadlines in a high-pressure environment.
• Good written, oral, and interpersonal communication skills.
• An ability to work well in an ambiguous environment with minimum supervision.
• Strong professional presence and business acumen.
• Innovative, proactive, and flexible to change.
• Self-motivation and a strong sense of ownership and accountability
• Exposure to process improvement methodologies with Lean Six sigma Green or Black belt an advantage

Experience

• Proven experience in data governance, data management, or related roles, preferably within a multinational organization operating in the Asia Pacific region.
• In-depth knowledge of data governance frameworks, principles, and best practices.
• Strong understanding of data quality management, data privacy regulations, and data-related compliance requirements.
• Demonstrable experience leading process change
• Superior vendor management experience
• Demonstrable knowledge and experience in SAP, SFDC, M365, BI and data analysis tools.

Job Duties:

• Manage the process for QMS audits, to ensure compliance of the organization’s Integrated Management Systems wrt ISO9001/TS16949/ VDA 6.3, Customer specific requirements.
• Identify areas/ system gaps for improvement and implementation. Establish and drive QMS enhancement and integration roadmap/milestones.
• Work closely with Operations and key stakeholders to maintain consistent manufacturing, quality policies and compliance
• Responsible for maintaining/improving fab performance though SPC program.
• Investigate root causes and resolve key fab-related quality issues and effectiveness of corrective and preventive actions. Manage Non-Conformance cases with respect to on-time closure with the relevant customers/Business Lines.
• Responsible for Outgoing and Periodic review OQA performance to drive defect reductions
• Responsible for Document Centre Management & Library Services
• Management of change among diverse cultures in a fast paced environment
• Co-work with related functions to support the wafer fabrication process to drive process/system optimization and effectiveness

Job Qualifications:

• Degree in Chemical / Electrical Engineering / Physics / Chemistry or equivalent
• 8+ years in semiconductor industry preferred
• Knowledge of wafer fabrication process essential
• Strong in project management skills, facilitation, analytical skills and system thinking

What a System Quality Program Manager does at HP:

Manage Quality Programs:

• Lead quality assurance programs from initiation through closure, ensuring alignment with project scope, goals, and deliverables.
• Oversee all aspects of quality program management, including planning, budget and resource control.
• Conduct System At Glance Test, Workflow Duration Test, and Continuous Regression Test.
• Support priority test projects with direction, maintaining relationships with internal stakeholders and sharing information with testers via standardized reports and regular stand-up meetings.

Collaborate with Cross-Functional Teams:

• Work closely with cross-functional teams to define program requirements, identify risks, and ensure successful project execution within defined timelines, resources and budgets.

Execute Quality Assurance Plans:

• Define and manage comprehensive test plans to ensure HP Print ecosystem integration quality.
• Oversee test coverage, schedules, and resource adjustments to meet program objectives.

Monitor and Analyse Quality Metrics:

• Track quality metrics to ensure compliance with HP’s standards, conduct data analysis to identify improvement areas, and drive continuous improvement initiatives.
• Lead Data-Driven Decision Making.

Facilitate Communication:

• Act as a primary quality contact for stakeholders, communicating program status, risks, and escalations effectively.
• Prepare and maintain QA-related documentation, including test plans, test matrices, and testing reports.
• Provide regular updates and insights to senior management.

Encourage a Culture of Innovation and Continuous Improvement:

• Promote a collaborative environment, integrating new technologies and quality methodologies, and driving process enhancements.

Individuals who do well in this role at HP, usually possess:

• Four-year Degree in Computer Science, Software Engineering, Information Systems, Information Technology, or any other related discipline or commensurate work experience or demonstrated competence.
• Typically has 0-1 years of work experience, preferably in software quality assurance, test harnesses and QA focused tools, or a related field.
• Good to have skills and knowledge: Agile Methodology, CI/CD, Computer Science, JIRA, Scrum (Software Development), Software Development, Software Engineering, Software Quality (SQA/SQC), Software Testing.
• Test Planning, Knowledge in Quality and defect management.
• Any certifications are a plus: Project Management Professional (PMP) Certification, Lean Six Sigma Certification or equivalent quality certifications, Certified Quality Engineer (CQE), Certified Software Quality Engineer (CSQE), Certified Software Quality Engineer, Certified Associate in Software Quality (CASQ), Certified Software Test Engineer (CSTE).

Sustainable impact is HP’s commitment to create positive, lasting change for the planet, its people, and our communities. This serves as a guiding principle for delivering on our corporate vision – to create technology that makes life better for everyone, everywhere.

HP is a Human Capital Partner – we commit to human capital development and adopting progressive workplace practices in Singapore.

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.

Responsibilities:

• Oversees project costing, budget allocation, expenditure monitoring and cost forecasting
• Reviews the project revenue update and project cash flow
• Oversees Change Order Management and Claims with clients, vendors and subcontractors
• Ensures timely commercial and cost reporting
• Reviews and evaluates vendors and subcontractors CBEs
• Coordinates with respective stakeholders for payment milestone requirements

Requirements:

• Bachelor’s Degree in any Engineering disciplines
• Minimum 5 years of relevant experience as project control manager
• Possess good communication and interpersonal skills

Our Addresses and Working Hours:

Seatrium (SG) Pte. Ltd.

Tuas Yard

51 Pioneer Sector 1, Singapore 628437

(Islandwide transport provided)

Mon - Thu: 8:00am – 5:15pm

Fri: 8:00am – 4:30pm

Interested candidates are invited to send us an updated resume with your current and expected salary and earliest availability.

We regret that only shortlisted candidates will be notified.

Please note that your personal data disclosed to Seatrium Limited and our group of companies, shall be used for the purposes of evaluation, and processing in accordance with our recruitment processes and policies. By providing your personal data, you have consented to the aforesaid purpose under the provisions of the Personal Data Protection Act 2012.

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.