Experience 3–7 years of relevant experience in API production/manufacturing, preferably in a GMP-regulated pharmaceutical facility. Job Overview Responsible for executing and monitoring API manufacturing operations as per approved batch manufacturing procedures, SOPs, GMP requirements, safety standards, and production plans. The position will coordinate with QA, QC, Engineering, Warehouse, and EHS to ensure safe, efficient, and compliant batch manufacturing. Key Responsibilities Execute API manufacturing activities as per approved BMR/BPR, SOPs, and manufacturing instructions. Monitor and control manufacturing processes and critical process parameters. Handle operations such as: Reactor charging and reaction Heating and cooling pH adjustment Extraction and separation Filtration and centrifugation Washing Drying Milling / sieving Blending Packing and material transfer Ensure production activities are completed according to the approved production schedule. Operate and monitor manufacturing equipment safely and efficiently. Verify raw materials, intermediates, solvents, and other materials before use. Ensure proper equipment cleaning, line clearance, and area readiness before batch operations. Complete batch documentation accurately and in accordance with Good Documentation Practices (GDP). Monitor process parameters and immediately report abnormalities or deviations. Initiate and support deviation investigations, CAPA, change control, and root-cause analysis. Coordinate with QA/QC for sampling, in-process testing, and batch release activities. Coordinate with Engineering/Maintenance for equipment breakdowns and maintenance requirements. Ensure compliance with cGMP, SOPs, EHS requirements, and data-integrity principles. Maintain proper housekeeping and 5S in production areas. Ensure safe handling of chemicals, solvents, intermediates, and APIs. Conduct shift handovers and communicate batch status, issues, and pending activities. Train and guide operators on manufacturing procedures, GMP, safety, and equipment operation. Support process validation, cleaning validation, technology transfer, scale-up, and trial batches. Participate in internal, customer, and regulatory audits and provide required documentation/support. Monitor production losses, yields, cycle times, and process efficiency. Technical Knowledge Good understanding of API manufacturing processes. Knowledge of chemical reactions and process parameters. Understanding of reactors, centrifuges, filters, dryers, mills, blenders, pumps, and vacuum systems. Knowledge of cGMP, GDP, ALCOA+ data integrity principles, and pharmaceutical documentation. Understanding of deviation, CAPA, change control, and risk-management processes. Knowledge of process safety and hazardous chemical/solvent handling. Qualification B.E./B.Tech – Chemical Engineering or M.Sc. Chemistry / B.Pharm / M.Pharm, depending on the organization's requirements. Key Competencies API manufacturing knowledge Batch execution GMP compliance Process monitoring Documentation Problem-solving Team coordination Safety awareness Cross-functional communication Production planning and execution Key Performance Indicators (KPIs) Production plan achievement Batch cycle-time adherence Batch yield and productivity Right-First-Time (RFT) performance Reduction in production deviations GMP/documentation compliance Equipment utilization Reduction in process losses