GM Operation

Job Description:

Position:       GM Operation

Location:      Bhopal

Experience:  18 - 25  Years

Industries:   Pharma

Responsibilities:

• Sterile Operations & Production Management
• Oversee aseptic processing, formulation, sterile filtration, and fill-finish operations (isolator technology, restricted access barrier systems - RABS, and lyophilization).
• Drive production scheduling and capacity utilization while minimizing batch failures, line contamination, or sterile breaches.
• Manage tech transfers, scale-up processes, and commercial manufacturing execution.
• Quality & Regulatory Compliance
• Maintain strict adherence to current Good Manufacturing Practices (cGMP), data integrity mandates, and contamination control strategies (CCS).
• Lead cross-functional readiness and face global regulatory authorities (USFDA, EU-GMP, WHO) during site inspections and audits.
• Review and approve critical deviations, root cause analysis (OOS/OOT), CAPAs (Corrective and Preventive Actions), and change controls.
• Cross-Functional Leadership & Administration
• Direct multi-departmental teams including Production, Quality Assurance (QA), Quality Control (QC), Engineering & Maintenance, Supply Chain/Warehouse, MSAT (Manufacturing Science and Technology), and EHS (Environment, Health, and Safety).
• Oversee facility maintenance, critical utilities (WFI, clean steam, HVAC, compressed gases), and calibration programs.
• Financial & Resource Optimization
• Manage annual plant budgets, capital expenditure (CapEx) for facility upgrades, and operational cost controls.
• Implement Lean manufacturing and Operational Excellence (OE) frameworks to reduce cycle times and improve overall equipment effectiveness (OEE).

Required Skills

• Strong knowledge of aseptic practices and cleanroom management.
• Expertise in cold-chain handling and logistics.
• Good understanding of biological product behavior and stability.
• Knowledge of protein aggregation and shear-sensitive products.
• Experience in regulatory audits, compliance and documentation

Required Qualification: - B.Pharm/M.Pharm/M.Sc. - (Biotech/Microbiology)

Salary: - Upto 35.00 LPA

If you are interested in this opening, please send updated resume on same mail with following details.

Total No. of Years Experience: -

Current CTC: -

Expected CTC: -

Notice Period: -