About the role
Production OSD: Officer Shop-Floor Operations: Execute and supervise daily manufacturing operations across Granulation, Compression, Capsule filling, and Coating stages to hit target quantities. Equipment Handling: Operate and monitor core OSD machinery (e.g., RMG, FBD, Rotary Tablet Presses, Auto-Coaters) following validated process parameters. BMR/BPR Documentation: Fill out and maintain real-time entries in Batch Manufacturing Records (BMR), Batch Packing Records (BPR), and equipment logbooks adhering strictly to ALCOA+ data integrity principles. Line Clearance: Perform and verify thorough cleaning (Type A/B) and line clearance checks at equipment and area changeovers to prevent cross-contamination or mix-ups. In-Process Quality Control (IPQC): Conduct routine IPQC tests (weight variation, thickness, hardness, friability, disintegration time, DT/leak tests) and record data promptly. QMS Participation: Report shop-floor incidents or process deviations immediately to senior management and assist in initial investigation logging and CAPA implementation. Yield & Material Reconciliation: Calculate stage-wise product yields, verify raw/packaging material quantities, and manage dispensing/reconciliation records accurately. Operator Guidance: Direct and guide machine operators and shop-floor helpers on daily operational tasks, cleanroom discipline, and machine safety. Audit Compliance: Keep work areas, processing rooms, and real-time records organized and ready for continuous internal and external regulatory audits (USFDA, MHRA, WHO). Safety & Cleanroom Hygiene: Enforce personal hygiene, proper cleanroom gowning practices, and strict adherence to plant EHS guidelines and PPE usage.