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 robust EHS culture across the plant.

📌 Manager - Production @ Kazipalli (Hyderabad)
🏢 Hetero
📍 Hyderabad