Plan, coordinate, and monitor daily production activities to achieve monthly and annual production targets. Ensure manufacturing operations are executed in accordance with approved Batch Manufacturing Records (BMRs), SOPs, process parameters, and regulatory requirements. Supervise API manufacturing processes, including reaction, filtration, centrifugation, drying, milling, blending, micronization, and packing operations. Drive production efficiency by optimizing batch cycle times, yields, equipment utilization, and resource allocation. Ensure compliance with cGMP, Good Documentation Practices (GDP), data integrity principles (ALCOA+), and EHS requirements. Review and approve batch records, equipment logbooks, shift reports, and production documentation. Lead investigations related to deviations, incidents, out-of-specification (OOS) results, process failures, and customer complaints; ensure timely implementation of CAPAs. Coordinate process validation, cleaning validation, technology transfer, scale-up activities, and new product introductions. Collaborate with Quality Assurance, Quality Control, Warehouse, Engineering, EHS, and Planning teams to ensure uninterrupted production operations. Monitor inventory levels of raw materials, intermediates, solvents, and consumables to avoid production delays. Ensure compliance with permit-to-work systems, hazardous chemical handling procedures, and process safety requirements. Lead manpower planning, shift scheduling, performance management, and capability development of production teams. Identify and implement continuous improvement initiatives focused on productivity enhancement, cost reduction, waste minimization, and energy conservation. Participate in internal audits, customer audits, and regulatory inspections, ensuring audit readiness at all times.
