Out Client is looking for a Quality Assurance Manger, to ensure strict compliance with Good Manufacturing Practice (GMP) and international regulatory guidelines across all plant activities including manufacturing, analysis, and batch release while maintaining the highest standards of product quality and safety.
Key Responsibilities:
- Quality System & Audits: Oversee the QMS, manage deviations, CAPAs, and change controls, and lead internal/external audits (customer and regulatory).
- Batch Release (QP Role): Act as Qualified Person to review batch records, investigate OOS/OOT events, and approve, release, or reject finished batches for sale/export.
- Documentation & Continuous Improvement: Approve SOPs, Master Batch Records, analytical methods, and Annual Product Reviews (APRs), while driving quality trends.
- Supplier & Validation QA: Approve vendors, ensure Technical Agreements are in place, and oversee equipment and process validation programs.
- Cross-Functional & Training: Conduct GMP training and partner with R&D, Production, and QC to resolve quality issues.
- Regulatory Compliance: Main liaison for national Health Authorities regarding compliance matters and safety escalations.
Requirements
- Science-based degree (Pharmacy, Chemistry, or similar) with eligibility to act as a Qualified Person (QP).
- Minimum 5 years in QA within a regulated pharmaceutical/API environment.
- In-depth knowledge of cGMP/GDP, batch release procedures, QMS, and root-cause investigation.
