12 Oct
|
Sanra Biosciences
|
Ahmedabad
12 Oct
Sanra Biosciences
Ahmedabad
Role Overview
We are seeking a Microbiologist to execute and oversee microbiological testing for a sterile injectable pharmaceutical facility. You will ensure full compliance with cGMP, pharmacopoeial standards, and company SOPs, directly supporting routine testing, water/utility monitoring, and retain sample management.
Key Responsibilities
- Core Testing &
- Analysis:
Perform Bacterial Endotoxin Testing (BET), Sterility Testing, and Microbial Limit Testing (MLT) using validated aseptic methods.
- Water &
- Utility Monitoring:
Conduct routine testing of Water for Injection (WFI), Purified Water, and process utility samples.
- Stability &
- Retains:
Execute stability study testing per schedules and manage the retain sample lifecycle (receipt, inventory, storage, and reconciliation).
- Media &
- Culture Control:
Prepare and maintain microbiology media, test reagents, and reference cultures, ensuring growth promotion and suitability testing are complete.
- Lab Compliance &
- Equipment:
Maintain cleanroom integrity, LAF/BSC workstations, autoclaves, and incubators; support environmental/viable monitoring.
- Documentation &
- Data Integrity:
Maintain test records, logbooks, and worksheets in line with Valuable Documentation Practices (GDP) and ALCOA+ principles.
- Deviations &
- Investigations:
Escalates invalid, OOS/OOT, or atypical results immediately and assist with root-cause investigations.
📌 QC Microbiologist (Ahmedabad)
🏢 Sanra Biosciences
📍 Ahmedabad