Production OSD - Executive
Job Description
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.