Associate Manager – Manufacturing Quality Assurance

About the role

Pfizer is seeking an Associate Manager to lead Manufacturing Quality Assurance (MQA) for Terminal Sterilization, Visual Inspection, and Packaging operations. You will ensure cGMP compliance, safeguard product quality, and support regulatory inspections, directly impacting patient safety.

Key responsibilities

• Maintain operating state of cGMP compliance across sterilization, inspection, and packaging lines.
• Review electronic batch records (eBR), assess AMP exceptions, and validate recipes.
• Perform Acceptable Quality Level sampling, record results, and conduct batch start‑up and end activities.
• Execute random process checks, daily walkthroughs, and equipment breakdown assessments.
• Analyze equipment alarms, quarterly alarm trends, and support troubleshooting.
• Identify process gaps, simplify procedures, and reduce downtime.
• Lead interactions with regulatory, corporate, and internal auditors/inspectors.

Required profile

• B.Pharm, M.Pharm or MSc with 6‑8 years of QA/Production experience in a pharmaceutical manufacturing environment.
• Hands‑on knowledge of terminal sterilization, visual inspection, and packaging processes.
• Experience handling USFDA, MHRA, TGA (or similar) inspections.
• Strong problem‑solving mindset, effective communication, and ability to work across teams.

Required skills

• cGMP compliance
• Terminal sterilization process
• Visual inspection
• Packaging operations
• Electronic batch records (eBR)
• AMPs (Advanced Manufacturing Practices)
• Microsoft Excel
• Microsoft Word