QA Specialist (Contract, Pharma, West) #HYN
Singapore | Posted: Nov 11, 2025
Job Scope
- Review and approve GMP documentation to ensure compliance with the Quality Standards.
- Qualify and manage vendors in accordance with PQS requirements, maintaining accurate and up-to-date records of vendor status. Review and analyze vendor-related quality issues, recommend corrective and preventive actions, and ensure vendors and materials remain qualified to support production schedules.
- Conduct internal audits to verify the effectiveness of internal controls and external audits to ensure robust vendor oversight. Collaborate with vendors to address and minimize material quality issues.
- Manage logistics and coordination for internal and external GMP inspections, including site communication and training. Maintain continuous inspection readiness and provide support during regulatory and customer inspections. Participate in GMP walkdowns to ensure operations and facilities remain inspection-ready and compliant with site procedures and PQS.
- Facilitate the preparation of regulatory submissions and ensure timely responses to regulatory queries.
- Coordinate and participate in gap analyses of site procedures against PQS and Policy Memos. Work with Subject Matter Experts (SMEs) to identify gaps, propose actions, and ensure timely implementation of mitigation measures.
- Maintain and monitor quality tracking systems and metrics to proactively identify trends and deviations. Support the preparation and coordination of monthly and ad-hoc Site Quality Review Team (SQRT) meetings.
- Uphold Code of Conduct and organizational values. Actively contribute to Tier meetings by updating performance metrics, escalating issues appropriately, and driving timely resolution. Collaborate cross-functionally to ensure seamless execution of site objectives.
- Participate in site safety initiatives and conduct or support Environment, Health, and Safety (EHS) investigations as required.
Requirement:
- A Bachelor Degree in Science / Chemical Engineering or equivalent with relevant pharmaceutical experience.
- A Minimum 3–5 years’ experience in pharmaceutical GMP-regulated industries (Biotech preferred) and min 3 years’ thereof in Quality Assurance/Compliance roles within the pharmaceutical industry.
Interested to find out more:
Please send your resume to:ashley.loo@recruitexpress.com.sg
We regret to inform that only shortlisted candidates will be notified.
Ashley Loo Yan Ni | R2095115 | EA License Number: 99C4599
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