Manager - Production @ Kazipalli

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.