15 Aug
|
Hetero
|
Hyderabad
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 recent product introductions, capacity expansion, and technology transfer projects.
Ensure adherence to safety policies and promote a solid EHS culture across the plant.
📌 Manager Production @ Kazipalli Hyderabad
🏢 Hetero
📍 Hyderabad