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Key Responsibilities

Oversee entire Plant Operations including Production, Warehouse, Engineering, HR, Commercial, and Government Liaison activities
Manage manufacturing and packing of all dosage forms except Injectables, ensuring cGMP compliance and adherence to USFDA and other regulatory standards
Ensure operational excellence in Man, Machine, and Material management
Handle regulatory audits including USFDA, WHO-GMP, MHRA, and ROW audits
Prepare and control operational budgets, monitor KPIs, and ensure cost-effective operations
Lead training and development initiatives for plant personnel
Ensure statutory compliance and safety across all plant operations
Implement best practices for process improvement, quality control, and operational efficiency

Preferred Candidate Profile

B.Pharm / M.Pharm with minimum 20 years of experience in Plant Operations for Pharma formulations (all dosage forms except Injectable)
Proven experience in managing USFDA-approved facilities and other regulated markets
Strong knowledge of cGMP compliance, regulatory audits (USFDA, MHRA, WHO-GMP), and operational management
Hands-on experience in managing Production, Warehouse, Engineering, HR, and Commercial functions
Strong leadership, people management, and decision-making skills with experience handling 1000+ employees

"Usfda" Jobs