Execute and supervise API manufacturing activities as per approved BMRs, SOPs, process parameters, and production plans. Operate and monitor process equipment, including reactors, centrifuges, filters, dryers, micronizers, blenders, and solvent recovery systems. Ensure adherence to critical process parameters, batch cycle times, yield targets, and production schedules. Review batch documentation, equipment logbooks, and shift records to ensure accuracy and compliance with Good Documentation Practices (GDP). Perform and verify line clearance, equipment cleaning status, and area readiness before batch initiation. Coordinate with Quality Assurance and Quality Control teams for in-process checks, sampling, material release, and batch disposition activities. Monitor raw material consumption, solvent usage, and process losses to optimize cost and improve operational efficiency. Investigate deviations, incidents, process abnormalities, and yield variances; implement corrective and preventive actions (CAPAs). Ensure compliance with current Good Manufacturing Practices (cGMP), data integrity principles (ALCOA+), and Environmental, Health & Safety (EHS) requirements. Coordinate with Engineering, Utilities, Warehouse, and EHS teams to ensure uninterrupted operations. Support process validation, cleaning validation, technology transfer, scale-up, and new product introduction activities.
