Execute API manufacturing activities including charging, reaction monitoring, filtration, centrifugation, drying, milling, blending, and packing as per approved BMR and SOPs. Monitor critical process parameters such as temperature, pressure, vacuum, pH, agitation, and reaction time to ensure process consistency. Operate and monitor process equipment including reactors, centrifuges, ANFDs, dryers, filters, mills, blenders, and associated utility systems. Ensure timely completion of batch manufacturing activities to achieve production schedules and delivery commitments. Maintain accurate Batch Manufacturing Records (BMR), logbooks, equipment usage records, and production documentation in compliance with Good Documentation Practices (GDP). Coordinate with QA for line clearance, in-process checks, and batch documentation review. Coordinate with QC for sampling, in-process testing, and release of intermediates and finished products. Ensure proper cleaning, line clearance, and status labeling of equipment and production areas. Report and participate in investigations related to deviations, incidents, process abnormalities, OOS, OOT, Change Controls, and CAPA implementation. Ensure compliance with cGMP, EHS, SOPs, and Data Integrity (ALCOA+) requirements. Optimize process yield, productivity, cycle time, and resource utilization. Coordinate with Engineering for preventive maintenance, breakdown maintenance, and equipment readiness. Train and supervise operators and technicians on safe manufacturing practices and GMP requirements. Implement Lean Manufacturing, 5S, Kaizen, and continuous improvement initiatives
