Production - Senior Executive
Bioksha
- Location
- Gujarat, India
- Job type
- Full-time
Required skills
- compliance
- Root Cause Analysis
About the role
Website:
bioksha.in
Job details:
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 standards, and conduct routine technical cGMP training for shop-floor personnel.
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