Execute manufacturing activities for API intermediates and finished active pharmaceutical ingredients as per approved Batch Manufacturing Records (BMRs), SOPs, and production plans. Operate and monitor process equipment such as reactors, centrifuges, filters, dryers, micronizers, blenders, and associated utility systems. Ensure adherence to process parameters, critical process controls, and yield targets during manufacturing operations. Perform line clearance activities and verify equipment cleanliness before batch initiation. Monitor and document production activities, including batch records, equipment logbooks, and process checklists. Coordinate with Quality Assurance and Quality Control teams for in-process sampling, material release, and batch documentation review. Ensure compliance with cGMP, Good Documentation Practices (GDP), data integrity principles (ALCOA+), and EHS requirements. Investigate and report deviations, incidents, process abnormalities, and safety concerns; support CAPA implementation. Coordinate with Warehouse, Engineering, EHS, and Utilities teams to ensure uninterrupted manufacturing operations. Monitor raw material consumption, process yields, cycle times, and wastage to optimize productivity and reduce costs. Support technology transfer, process validation, cleaning validation, and scale-up activities. Ensure effective manpower utilization and provide on-the-job training to operators and contract workforce. Maintain housekeeping standards and promote a safe working environment. Participate in internal audits, customer audits, and regulatory inspections.
