Manager

Description

Plan, coordinate, and supervise day-to-day API manufacturing operations in accordance with the approved production plan. Ensure timely execution of batches as per Batch Manufacturing Records (BMRs), SOPs, validated processes, and approved procedures. Monitor critical process parameters and ensure manufacturing activities remain within approved operating ranges. Supervise processes such as charging, reaction, heating/cooling, extraction, filtration, centrifugation, distillation, solvent recovery, drying, milling, and packing, as applicable. Ensure optimum utilization of manpower, equipment, utilities, raw materials, and solvents. Monitor production yield, cycle time, productivity, and material consumption. Identify opportunities for process optimization, yield improvement, cycle-time reduction, and cost reduction. Prepare and execute daily, weekly, and monthly production plans in coordination with Planning and other departments. Ensure availability of raw materials, solvents, equipment, manpower, and utilities for planned production. Coordinate with QA, QC, Engineering, Warehouse, EHS, Maintenance, and R&D to ensure smooth batch execution. Monitor production schedules and take corrective action to minimize delays and downtime. Ensure timely completion and review of production documentation. Ensure manufacturing activities comply with cGMP, SOPs, BMRs, safety procedures, and regulatory requirements. Ensure proper documentation of all manufacturing activities and process parameters. Review BMRs, equipment logbooks, cleaning records, and other production documents. Ensure adherence to data-integrity and Good Documentation Practices (GDP). Lead or support investigations related to deviations, OOS/OOT, process failures, yield variations, and other manufacturing incidents. Support implementation of CAPA, change controls, and continuous improvement actions. Ensure proper operation, cleaning, and maintenance of production equipment. Coordinate with Engineering/Maintenance for equipment breakdowns and preventive maintenance. Monitor equipment utilization and identify recurring equipment-related issues. Ensure proper equipment status labeling and line clearance. Support qualification/validation activities related to production equipment and processes. Ensure strict compliance with EHS and process-safety requirements. Ensure safe handling of hazardous chemicals, solvents, gases, and process materials. Monitor compliance with PPE requirements and safe operating procedures. Investigate and implement corrective actions for safety incidents and near misses. Ensure good housekeeping and 5S practices throughout the production area.