Job DescriptionWe are hiring a dedicated IPQA Officer for our Active Pharmaceutical Ingredient (API) manufacturing facility. You will monitor shop-floor operations to ensure strict compliance with cGMP, regulatory guidelines, and standard operating procedures (SOPs).Key Responsibilities
Line Clearance: Grant line clearance for manufacturing, dispensing, and packaging steps.
Shop-floor Monitoring: Conduct regular plant rounds to audit ongoing API unit operations.
Sampling: Draw in-process, intermediate, and final API samples per protocols.
Batch Records: Review Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) in real-time.
Deviations: Identify, document, and report shop-floor deviations and non-conformances immediately.
Data Integrity:
Verify online documentation practices across production areas.
Validation Support: Assist in data collection for equipment qualification and process validation.
Required Profile
Education: B.Sc / M.Sc (Chemistry) or B.Pharm / M.Pharm.
Experience: Minimum 01 years of core IPQA experience in an API manufacturing plant.
Skills: Robust knowledge of cGMP, ICH Q7 guidelines, and cleanroom practices.
Competencies: High attention to detail, positive documentation habits, and transparent communication.