Senior Executive Job in Cadila Pharmaceuticals Ltd at Ankleshwar

Experience 5–10 years of experience in API manufacturing, preferably in a regulated pharmaceutical manufacturing environment. Job Overview Responsible for managing day-to-day production activities during the assigned shift, ensuring safe, efficient, and compliant manufacturing of APIs while meeting production targets, quality requirements, and GMP standards. Key Responsibilities Manage complete API production activities during the assigned shift. Execute manufacturing processes as per approved BMR/BPR, SOPs, and validated procedures. Ensure production targets are achieved while maintaining product quality and safety. Monitor critical process parameters and ensure adherence to approved process conditions. Coordinate with QA, QC, Engineering, Warehouse, EHS, and Maintenance teams for smooth production operations. Ensure proper manpower allocation and effective utilization of production resources. Review batch documentation and ensure accurate, timely recording of manufacturing activities. Identify process deviations, abnormalities, and equipment issues and escalate them appropriately. Initiate and participate in deviation, CAPA, change control, and investigation activities. Ensure compliance with cGMP, SOPs, data integrity, safety procedures, and regulatory requirements. Monitor equipment condition and coordinate with Engineering/Maintenance for breakdowns and preventive maintenance. Ensure proper cleaning, line clearance, housekeeping, and material management in production areas. Conduct shift handover and communicate production status, issues, and pending activities to the incoming shift. Ensure proper handling of solvents, chemicals, intermediates, and APIs in accordance with safety procedures. Support process validation, cleaning validation, technology transfer, and scale-up activities when required. Train and guide production operators and junior staff on SOPs, GMP, safety, and process requirements. Prepare and review shift production reports and communicate key operational issues to management. Participate in internal, customer, and regulatory audits and support timely closure of observations. Technical Knowledge Strong knowledge of API manufacturing processes such as reaction, filtration, centrifugation, drying, milling, blending, and solvent recovery. Knowledge of chemical handling and process safety. Understanding of cGMP, GLP, GDP, ALCOA+ data integrity principles, and pharmaceutical documentation practices. Familiarity with batch manufacturing records and electronic manufacturing systems. Knowledge of process equipment and basic troubleshooting. Understanding of validation, deviation, CAPA, change control, and risk assessment processes. Leadership Responsibilities Lead production operators and technicians during the shift. Allocate manpower according to production priorities. Ensure discipline, productivity, and adherence to safety requirements. Coach team members and identify training requirements. Coordinate effectively with cross-functional departments during batch execution and emergencies. Qualification B.E./B.Tech/M.Tech in Chemical Engineering or B.Pharm/M.Pharm/M.Sc. Chemistry, depending on the organization's requirements. Key Performance Indicators (KPIs) Achievement of production plan. Batch cycle-time adherence. Right-first-time (RFT) / batch success rate. Reduction in deviations and production losses. Compliance with GMP and safety requirements. Equipment utilization and downtime. Yield and solvent recovery performance. Timely completion of batch documentation. Team productivity and training compliance.