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 (Workplace, 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
Robust 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 regulator

📌 Gm Operation Bhopal
🏢 Quality HR India
📍 Bhopal