Execute API manufacturing batches as per Batch Manufacturing Records (BMR), SOPs, and approved process parameters. Independently handle shift production activities including charging, reaction monitoring, filtration, centrifugation, drying, blending, milling, and packing. Monitor critical process parameters and ensure optimum yield, productivity, and batch quality. Coordinate production planning to meet daily and monthly manufacturing targets. Lead operators, technicians, and contract manpower during shifts. Allocate work, monitor productivity, and ensure adherence to production schedules. Train and mentor junior executives and operators on GMP, SOPs, and safe work practices. Review and maintain BMRs, equipment logbooks, cleaning records, and shift reports. Ensure compliance with cGMP, GDP, Data Integrity (ALCOA+), and regulatory requirements. Report and investigate deviations, incidents, and out-of-limit observations.
