Manager - Production @ Kazipalli

Hetero; Telangana; On-site; INR 1,200,000 - 1,600,000; Full time

Job summary

Hetero is seeking a senior operations professional to lead end-to-end API production activities in Telangana. The role focuses on managing batch manufacturing, process validation, technology transfer, and ongoing compliance with cGMP and global regulatory standards.

The incumbent will drive continuous improvement, monitor KPI performance, and coordinate with QA, QC, Engineering, Warehouse, Planning, and Supply Chain to ensure smooth manufacturing and timely commercial production.

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.

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.