- Shop-Floor Compliance: Monitors daily manufacturing and packaging operations in real time to ensure strict adherence to cGMP and SOPs.
- Line Clearance: Inspects equipment, lines, and processing areas before every recent batch to prevent product cross-contamination or mix-ups.
- In-Process Testing: Collects samples and performs routine physical tests like tablet hardness, thickness, friability, disintegration, pH, and fill volumes.
- Batch Record Verification: Checks and signs off on Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) at each stage of production.
- Environmental & Utility Checks: Assists in monitoring cleanroom environmental parameters (temperature, humidity, differential pressure) and utility sampling.
- Deviation & OOS Reporting:
Immediately escalates out-of-specification (OOS) results, process deviations, or line errors to senior QA managers.
- Instrument Calibration Verification: Ensures all shop-floor measuring instruments and testing devices are properly calibrated before use.
- Cross-Department Coordination: Acts as the primary quality liaison between shop-floor production operators, maintenance, and the central QA team.
- Target Industry & Education: Typically requires a B.Pharm, M.Pharm, or Chemistry degree and serves as an entry-level pathway toward Senior QA Executive and QMS Manager roles.
📌 Trainee officer - IPQA (Gujarat)
🏢 USV
📍 Gujarat