Description

Execute API manufacturing processes as per approved BMR, SOPs, process parameters, and production schedules. Supervise day-to-day production activities including charging, reaction, heating/cooling, distillation, extraction, filtration, centrifugation, drying, milling, and packing as applicable. Monitor critical process parameters and ensure operations are carried out within approved limits. Ensure accurate recording of process parameters, observations, yields, and material consumption in BMRs and relevant production documents. Verify raw materials, solvents, intermediates, and packaging materials before use. Coordinate with Quality Assurance, Quality Control, Engineering, Warehouse, and EHS for smooth production operations. Ensure compliance with cGMP, SOPs, safety procedures, and data-integrity requirements. Identify process deviations, abnormal observations, equipment issues, and yield variations and report them to the concerned supervisor/manager. Participate in deviation, CAPA, change control, OOS/OOT, and incident investigations as required. Ensure proper equipment cleaning, line clearance, area clearance, and status labeling before and after manufacturing operations. Monitor equipment performance and coordinate with Engineering for breakdowns, preventive maintenance, and troubleshooting. Maintain proper housekeeping and ensure production areas comply with GMP and EHS standards. Supervise and guide operators during manufacturing activities and ensure adherence to safety and operational procedures. Assist in process optimization, scale-up, technology transfer, validation, and process improvement activities. Ensure proper handling and transfer of hazardous chemicals, solvents,



and intermediates according to approved safety procedures. Monitor batch yield, cycle time, solvent recovery, and production efficiency. Ensure timely completion and review of production documentation. Support internal, customer, and regulatory audits by providing required production records and information. Participate in training programs and provide on-job training to production personnel. Educational Qualification B.Sc./M.Sc. in Chemistry B.Pharm/M.Pharm or equivalent qualification may also be considered. Diploma/degree in Chemical Engineering may be considered depending on the organization's requirements. Experience Typically 2–5 years of experience in API production/manufacturing in a pharmaceutical industry. Hands-on experience in chemical synthesis/API manufacturing processes is preferred. Experience working in a GMP-compliant manufacturing facility is required. Technical Skills Knowledge of API manufacturing processes Reaction and process parameter monitoring Filtration and centrifugation Drying and milling Solvent handling and recovery Equipment operation and troubleshooting BMR/BPR documentation GMP and GDP Deviation and CAPA awareness Change control Process validation Safety and EHS practices Behavioral Skills Positive communication and coordination skills Team handling and leadership ability Problem-solving skills Attention to detail Ability to work in shifts Ability to work under production timelines Strong documentation practices Safety-conscious approach Key Performance Indicators (KPIs) Batch completion within planned timelines Right-first-time batch execution Yield and productivity Compliance with BMR/SOP requirements Reduction in process deviations Equipment utilization GMP and safety compliance Documentation accuracy

📌 Senior Officer (India)
🏢 Cadila Pharmaceuticals
📍 India