Production OSD Executive

• Job Description: Production OSD Executive

  • Line Operations Management: Direct and monitor daily unit operations across Granulation Compression Capsule Filling and Coating sections to achieve production targets.

  • QMS Compliance & Investigation: Initiate and draft shop-floor Deviations perform Root Cause Analysis (RCA) and implement effective CAPAs and Change Controls.

  • BMR/BPR Review: Review completed Batch Manufacturing and Packing Records in real time to ensure total adherence to cGMP and ALCOA data integrity standards.

  • Line Clearance Execution: Supervise and verify strict line clearance and cleaning protocols (Type A/B) during product changeovers to eliminate cross-contamination risks.

  • In-Process Quality Control: Enforce routine IPQC monitoring (tablet weight hardness friability disintegration time DT/leak tests) to maintain critical quality attributes (CQAs).

  • Yield & Material Reconciliation: Calculate stage-wise batch yields perform material reconciliation and analyze variances to minimize process loss.

  • Process Validation Support: Participate in the execution of continuous process validation (PV) cleaning validation and equipment qualification protocols (IQ/OQ/PQ).

  • Manpower & Shift Allocation: Allocate work schedules and supervise shift officers machine operators and contract workers to maximize machine utilization.

  • Audit Readiness: Maintain cleanrooms logbooks and processing areas in a constant state of readiness for internal and external regulatory audits (USFDA MHRA WHO).

  • EHS & Safety Enforcement: Enforce shop-floor safety guidelines proper cleanroom gowning correct personal hygiene and mandatory usage of PPE.

Required Experience:

Exec