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 Valuable 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: -

📌 GM Operation (Bhopal)
🏢 Quality HR India
📍 Bhopal