Manager - Production @ Kazipalli

Job description

**Role & responsibilities** : - Lead and manage end-to-end API production operations to achieve production targets. - Plan, monitor, and optimize batch manufacturing activities for maximum productivity and efficiency. - Ensure compliance with cGMP, EHS, Data Integrity, and global regulatory requirements (USFDA, EU GMP, MHRA, PMDA, WHO-GMP). - Drive continuous improvement initiatives to enhance productivity, yield, and cost optimization. - Monitor production KPIs and implement corrective actions to improve operational performance. - Coordinate with QA, QC, Engineering, Warehouse, Planning, and Supply Chain for seamless manufacturing operations. - Ensure timely completion of process validation, technology transfer, engineering batches, and commercial production. - Review and approve Batch Manufacturing Records (BMR), SOPs, deviations, CAPA, change controls, and investigation reports. - Lead regulatory, customer, and internal audits and ensure timely closure of observations. - Ensure optimum utilization of manpower, equipment, and manufacturing resources. - Develop and mentor production teams to build a high-performance culture. - Support new product introductions, capacity expansion, and technology transfer projects. - Ensure adherence to safety policies and promote a strong EHS culture across the plant.