15 Aug
|
Azico Biophore India
|
Visakhapatnam
15 Aug
Azico Biophore India
Visakhapatnam
Role & responsibilities :
- Lead end-to-end plant operations covering Production, R&D;, Engineering, Maintenance, Utility Operations, Warehouse, EHS, and Projects.
- Ensure achievement of production plans, capacity utilization, yield improvement, and on-time product delivery.
- Drive operational excellence through process optimization, cycle time reduction, solvent recovery improvement, and cost reduction initiatives.
- Ensure compliance with cGMP, USFDA, EU GMP, WHO-GMP, ICH Guidelines, Data Integrity, and EHS regulations.
- Lead successful regulatory inspections, customer audits, and quality compliance programs.
- Manage multi-purpose API manufacturing blocks involving complex chemical reactions, hydrogenation, high-pressure operations, and solvent handling systems.
- Oversee engineering, preventive maintenance, utilities, and reliability programs to ensure uninterrupted operations.
- Lead technology transfer, scale-up activities, debottlenecking, and capacity expansion projects.
- Drive implementation of Lean Manufacturing, TPM, Six Sigma,
and continuous improvement initiatives.
- Ensure adherence to process safety management, environmental compliance, hazardous chemical handling, and sustainable manufacturing practices.
- Develop high-performing teams and foster a culture of accountability, safety, quality, and operational excellence.
Preferred candidate profile :
- Qualification: B.Tech/B.E. Chemical Engineering, M.Sc. Chemistry, M.Pharm or equivalent; MBA preferred.
- Experience: 18-25 years in Pharmaceutical API/Bulk Drug manufacturing with at least 8 years in senior plant leadership roles.
- Proven experience managing USFDA, EDQM, MHRA, PMDA, WHO-GMP approved facilities.
- Robust exposure to API process manufacturing, solvent recovery systems, utility management, process optimization, and regulatory compliance.
- Demonstrated success in leading large teams, expansion projects, and operational excellence programs.
📌 General Manager Operations (Visakhapatnam)
🏢 Azico Biophore India
📍 Visakhapatnam