Production OSD: Assistant Manager
- Production Operations Leadership: Lead and oversee daily manufacturing schedules across Granulation, Compression, Coating, and Capsule filling sections to consistently meet production targets and optimize line efficiency.
- QMS Management & Investigations: Drive shop-floor Quality Management System compliance by initiating, investigating, and closing Deviations, CAPAs, Change Controls, and OOS/OOT occurrences using RCA methodologies (e.g., Fishbone, 5-Why).
- BMR/BPR Final Technical Review: Perform final, high-level technical reviews of completed Batch Manufacturing and Packing Records to guarantee total compliance with ALCOA+ data integrity principles prior to QA batch release.
- Audit Representation & SME: Act as a technical Subject Matter Expert (SME) during internal and external regulatory inspections (USFDA, MHRA, EMA, WHO), presenting shop-floor practices, logbooks, and process controls.
- Process & Cleaning Validation: Coordinate and supervise the execution of continuous Process Validation (PV), cleaning validation,
and equipment qualification protocols (IQ/OQ/PQ) for scale-up and current product launches.
- Yield Improvement & Capacity Planning: Analyze stage-wise batch yields, perform complex material reconciliations, and drive Lean/5S initiatives to minimize process losses, reduce cycle times, and expand capacity.
- Cross-Functional Alignment: Work closely with Production Planning and Control (PPC), Quality Assurance (QA), Quality Control (QC), Engineering, and Tech Transfer to ensure seamless raw material availability and minimize equipment downtime.
- Equipment & Automation Optimization: Oversee the operational performance of high-speed OSD equipment (e.g., RMG, FBD, auto-coaters, rotary tablet presses) and evaluate automation upgrades to boost productivity.
- Team Supervision & Skill Development: Manage shift officers, executives, and operators; evaluate team performance, design training matrices, and foster a strong cult
📌 Production - Assistant Manager (Diu)
🏢 USV
📍 Diu