Manager

Job Description Manager, Quality Control (Sterile/Injectable)

Department: Quality Control
Designation: Manager QC
Location: Nagpur
Area: Sterile / Injectable Manufacturing

Key Responsibilities

• Lead QC activities supporting sterile/injectable manufacturing.
• Ensure laboratory activities comply with cGMP and applicable regulatory requirements.
• Manage investigations, QRM, deviations and related laboratory compliance activities.
• Support regulatory inspections and prepare responses to audit observations.
• Oversee environmental monitoring and contamination-control activities associated with aseptic areas.
• Review trends for viable/non-viable monitoring and other microbiological monitoring programs.
• Ensure appropriate control of sterility testing, BET/endotoxin, bioburden, microbial identification and growth-promotion testing.
• Support media fills, aseptic process validation and contamination investigations.
• Oversee PW/WFI microbiological monitoring and related utility controls.
• Manage and develop the QC team and ensure effective laboratory operations.

Technical Skills

• Sterility Testing
• BET / LAL
• Bioburden / MLT
• AET
• Environmental Monitoring
• Viable & Non-Viable Monitoring
• Media Fill / Aseptic Process Validation
• Contamination Control Strategy (CCS)
• Grade A/B/C/D operations
• QRM and investigation tools
• LIMS
• PW/WFI microbiology
• Method Validation
• Audit Compliance

These technical areas closely reflect the internal sterile Manager requirement.

Regulatory Exposure

Preference for candidates with exposure to:

• USFDA
• EU requirements / EU Annex 1
• TGA
• ANVISA
• PDA guidance

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