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

Send cv on [email protected]

📌 Manager (Nagpur)
🏢 LUPIN
📍 Nagpur