Production OSD: Senior Executive
Shop-Floor Execution & Supervision: Lead shift operations across Granulation, Compression, Coating, and Capsule filling to ensure production targets are achieved safely and on schedule.
QMS Investigation Lead: Own and drive shop-floor Quality Management System tasks, including drafting detailed Deviation reports, conducting Root Cause Analysis (RCA), and executing CAPA and Change Control actions.
Batch Record Review & Audit Readiness: Perform comprehensive technical reviews of executed Batch Manufacturing Records (BMR) and Batch Packing Records (BPR) to ensure strict ALCOA+ data integrity prior to QA submission.
Line Clearance & Cross-Contamination Prevention: Authorize and verify critical Type A/B line clearances, equipment washings, and room handovers during batch or product changeovers.
In-Process Quality Oversight: Monitor critical process parameters (CPPs) and critical quality attributes (CQAs) during processing, ensuring full compliance with IPQC standards and weight/hardness/disintegration limits.
Validation & Scale-Up Support:



Lead the floor execution of Process Validation (PV) batches, cleaning validation swabbing/sampling, and equipment qualifications (IQ/OQ/PQ) in coordination with Tech Transfer.
Yield Optimization & Material Reconciliation: Analyze stage-wise batch yields, execute material reconciliations, investigate raw material losses, and implement yield improvement initiatives.
Resource & Shift Scheduling: Manage floor operators, technicians, and shift staff; allocate machinery effectively to eliminate bottlenecks and optimize overall equipment effectiveness (OEE).
Audit SME Representation: Act as a front-line Subject Matter Expert (SME) during internal audits and regulatory inspections (USFDA, MHRA, WHO, EMA), presenting batch execution records and shop-floor controls.
EHS & Training Compliance: Enforce strict adherence to plant Environmental Health & Safety (EHS) policies, cleanroom gowning stan

📌 Production Senior Executive Diu
🏢 USV
📍 Diu