Lead and oversee day-to-day production activities across API manufacturing blocks, including reaction, filtration, centrifugation, drying, micronization, and packing operations. Ensure adherence to production plans to achieve output targets, cycle times, and on-time delivery commitments. Monitor batch execution and ensure compliance with approved Batch Manufacturing Records (BMRs), SOPs, and process parameters. Drive continuous improvements in yield, throughput, productivity, and resource utilization. Ensure strict adherence to cGMP, ICH, USFDA, EU GMP, MHRA, WHO, and other applicable regulatory requirements. Coordinate with Quality Assurance and Quality Control teams to ensure timely batch release and closure of deviations, CAPAs, change controls, and investigations. Lead audit readiness activities and support customer, regulatory, and internal audits. Ensure data integrity and compliance with EHS and quality systems. Monitor critical production KPIs such as batch cycle time, yield, OEE, right-first-time, and schedule adherence. Lead root cause analysis and implementation of corrective and preventive actions. People Leadership
