13 Oct
|
Sanra Biosciences
|
Ahmedabad
13 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