Production - Sr. Officer

Production OSD: Senior Officer

• Shop-Floor Supervision: Oversee shift-wise manufacturing activities across Granulation, Compression, Capsule filling, and Coating sections to meet daily production targets.
• Equipment Operation & Trouble Shooting: Operate, monitor, and assist operators with major OSD machinery (RMG, FBD, Rotary Tablet Presses, Auto-Coaters) while resolving minor line breakdown issues.
• BMR/BPR Real-Time Review: Verify and execute real-time BMR/BPR documentation, ensuring complete accuracy and strict compliance with ALCOA+ data integrity principles.
• Line Clearance Execution: Perform and sign off on Type A/B line clearance, equipment washings, and changeover verification checks between product runs to prevent cross-contamination.
• In-Process Quality Control (IPQC): Perform and supervise routine IPQC tests (weight variation, thickness, hardness, friability, disintegration time, DT/leak tests) to keep processes within validated parameters.
• QMS Documentation Support: Initiate initial reports for shop-floor deviations, support Root Cause Analysis (RCA) investigations, and execute assigned CAPAs and Change Control actions.
• Yield & Material Reconciliation: Perform stage-wise material reconciliation, verify raw and packaging material quantities, and report yield variances to section leads.
• Process Validation Support: Participate in the floor-level execution of continuous Process Validation (PV) runs, cleaning validation sampling, and equipment re-qualification activities.
• Audit Readiness & Cleanroom Upkeep: Maintain shift logbooks, room status boards, and processing areas in a continuous state of compliance for internal and regulatory audits (USFDA, MHRA, WHO).
• Team Guidance & EHS Compliance: Enforce EHS safety guidelines, correct usage of PPE, cleanroom gowning rules, and guide junior officers and operators on daily tasks.