Sr. Officer IPQA

• Shift Management: Supervise train and schedule IPQA officers inspectors or technicians across different production shifts.

• Line Clearances: Oversee and cross-verify strict line clearance protocols before starting new batches or shifting product lines to eliminate cross-contamination and mix-ups.

• Shop Floor Compliance: Conduct regular walkthroughs to ensure operators follow proper gowning (aseptic techniques) and behavior standards required for controlled cleanrooms.

• Testing Integrity: Monitor in-process tests performed by the team (e.g. checking tablet thickness weight variation hardness leak testing or fill volumes) to ensure precision.

• Environmental Monitoring: Supervise environmental parameters like room differential pressures temperature humidity and microbial/particle levels in cleanroom areas.

• Sampling Management: Coordinate sampling activities for routine batches stability studies validation trials and control retention.

• Batch Record Review: Perform online and real-time reviews of Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) to ensure all entries meet Good Documentation Practices (GDP).

• Logbook Audits: Audit shop floor logbooks equipment usage tags and calibration statuses.

• Incident Management: Act as the first point of contact when a process deviation failure or out-of-specification (OOS) result occurs on the floor.

• Root Cause Analysis (RCA): Partner with production and engineering to lead investigations into why a process failed.

• CAPA Implementation: Design and track Corrective and Preventive Actions (CAPA) to guarantee manufacturing hiccups dont repeat themselves.

• Participate directly in internal plant audits as well as external regulatory inspections.

• Ensure all paperwork tracking logs and physical production lines are continuously organized to face sudden unannounced regulatory sweeps.

Required Experience:

Senior IC