Execute API manufacturing processes as per approved BMR/BPR, SOPs, process parameters, and GMP requirements. Supervise production activities involving reactors, centrifuges, filters, dryers/RCVD, and associated process equipment. Monitor critical process parameters such as temperature, pressure, pH, reaction time, agitation, vacuum, and material charging. Ensure proper dispensing, charging, reaction, isolation, filtration, washing, drying, milling/sieving, and packing activities as applicable. Perform and coordinate in-process sampling and communicate with QC for testing and release of materials. Ensure accurate and timely completion of BMR/BPR, logbooks, equipment records, checklists, and other GMP documentation. Identify process deviations, abnormalities, and equipment issues and immediately escalate them to the concerned department. Support investigation of deviations, OOS/OOT, incidents, and process-related failures and implement approved CAPA. Ensure production operations are carried out according to approved procedures without unauthorized process changes. Coordinate with QA, QC, Engineering, Warehouse, EHS, and Maintenance for smooth production operations. Monitor raw material, solvent, consumable, and packaging-material availability for planned batches. Ensure equipment cleaning, line clearance, status labeling, and area housekeeping are maintained as per GMP. Follow all EHS, PPE, chemical handling, fire safety, and waste-management requirements. Support preventive maintenance activities and report equipment breakdowns promptly. Train and guide operators/workmen on SOPs, GMP, safety, and manufacturing practices. Monitor batch yield, cycle time, productivity, and material consumption and highlight deviations from standard performance. Participate in process optimization, yield improvement, cost reduction, and continuous improvement initiatives. Support internal, customer, regulatory, and GMP audits by ensuring production areas and documentation are inspection-ready. Maintain good housekeeping and 5S standards within the production area. Required Qualifications B.Sc./M.Sc. Chemistry, B.Pharm, M.Pharm, Chemical Engineering, or equivalent qualification. 2–5 years of relevant experience in API/pharmaceutical manufacturing. Hands-on experience in chemical/API manufacturing operations is preferred. Good knowledge of GMP, SOPs, BMR/BPR, deviation handling, and EHS requirements. Knowledge of batch manufacturing processes and production equipment. Good communication, documentation, problem-solving, and team-handling skills. Key Competencies API manufacturing process knowledge GMP & documentation compliance Production planning and execution Process troubleshooting Team supervision Safety awareness Deviation/CAPA understanding Yield and productivity improvement Cross-functional coordination Attention to detail Key Performance Indicators (KPIs) Batch completion as per production plan Batch yield and productivity Right-first-time / documentation accuracy GMP and audit compliance Reduction in deviations and process losses Equipment utilization and cycle-time adherence Safety performance Timely closure of production-related actions
