OSD Manufacturing - QMS/Compliance

- Daily Production Supervision: Plan, coordinate, and execute daily manufacturing schedules for OSD operations (dispensing, granulation, compression, coating, and capsule filling) to hit target volume metrics safely and on time. - cGMP & Regulatory Compliance: Ensure all manufacturing steps strictly comply with current Good Manufacturing Practices (cGMP), standard operating procedures (SOPs), and international regulatory guidelines (USFDA, EMA, WHO). - Batch Documentation & Review: Oversee the error-free execution of Batch Manufacturing Records (BMRs) and Batch Packaging Records (BPRs), conducting timely technical reviews prior to Quality Assurance (QA) release. - Shift & Team Leadership: Lead, train, and mentor production supervisors, team leaders, and operators, managing shift rosters, workload distribution, and performance evaluations. - Deviation & CAPA Management: Lead investigations into shop-floor deviations, out-of-specification (OOS) events, and equipment failures; design and implement robust Corrective and Preventive Actions (CAPA). - Yield & Operational Excellence: Monitor material usage, yield reconciliation, and batch productivity, leading Lean Manufacturing/Six Sigma initiatives to minimize cycle times, scrap, and material wastage. - Equipment Maintenance & Qualification: Collaborate with Engineering and Validation teams for scheduled maintenance, calibration, and IQ/OQ/PQ qualifications of core OSD equipment (e.g., fluid bed dryers, rotary tablet presses, capsule fillers). - Audit Readiness: Drive continuous audit readiness across the manufacturing plant, participating actively in external regulatory inspections and internal quality audits. - EHS & Shop-Floor Safety: Enforce strict Environmental Health & Safety (EHS) policies, ensuring proper containment protocols for high-potency APIs, use of Personal Protective Equipment (PPE), and ergonomic compliance.