Plan, coordinate, and execute day-to-day API manufacturing activities as per the approved production plan. Ensure manufacturing operations are carried out strictly as per BMR, SOPs, process instructions, and GMP requirements. Monitor critical process parameters and ensure operations remain within approved limits. Supervise activities including, as applicable, charging, reaction, distillation, extraction, filtration, centrifugation, drying, milling, blending, and packing. Ensure timely completion of batches while maintaining product quality, yield, and productivity. Review batch progress and communicate production status to the Production Manager/Plant Head. Effectively deploy manpower across production activities based on operational requirements. Lead, supervise, and motivate operators, technicians, officers, and other production personnel. Ensure adequate manpower availability for planned production activities. Conduct shift handovers and ensure clear communication of critical production information. Identify training requirements and support skill development of production personnel. Ensure strict compliance with cGMP, SOPs, safety procedures, and regulatory requirements. Review and verify production documentation, logbooks, BMRs, equipment records, and other manufacturing documents. Ensure accurate and timely documentation in accordance with Data Integrity principles. Maintain proper records of process parameters, yields, material consumption, and production activities. Ensure line clearance, equipment status, and area readiness before starting manufacturing operations. Coordinate with QA and QC for sampling, in-process checks, batch release activities, and quality-related requirements. Identify and report process deviations, incidents, and abnormal observations. Participate in investigations related to deviations, OOS/OOT, CAPA, change controls, and customer/regulatory observations, as applicable. Implement corrective and preventive actions within the production area. Promote a strong quality culture within the production team.
