Execute manufacturing operations as per approved Batch Manufacturing Records (BMR), SOPs, and production plans. Supervise shift activities and ensure timely completion of production batches. Handle chemical reactions, crystallization, filtration, drying, milling, blending, and packing activities. Monitor critical process parameters and ensure compliance with process specifications. Ensure line clearance, equipment cleaning, and status labeling before batch initiation. Review and complete BMRs, logbooks, equipment records, and production documentation following Good Documentation Practices (GDP). Coordinate with QA, QC, Engineering, Warehouse, EHS, and Maintenance for smooth manufacturing operations. Investigate deviations, incidents, OOS/OOT observations, and implement CAPA in coordination with QA. Ensure compliance with cGMP, Data Integrity, EHS guidelines, and regulatory requirements. Optimize process yield, reduce cycle time, minimize solvent consumption, and improve productivity. Monitor utility consumption and ensure effective utilization of manpower and equipment.
