QC Microbiologist

Sanra Biosciences; Sanand; On-site; INR 450,000 - 600,000; Full time

Job summary

Sanra Biosciences in Gujarat, India seeks a Microbiologist to execute and oversee microbiological testing for a sterile injectable pharmaceutical facility. You will ensure compliance with cGMP, pharmacopoeial standards and company SOPs, supporting routine testing, water/utility monitoring, and retain sample management.

The role covers BET, Sterility Testing, MLT, WFI and Purified Water testing, stability studies, media preparation, GDP/ALCOA+ documentation, and deviation investigations.

Qualifications

• Perform BET, Sterility Testing, and MLT using validated aseptic methods.
• Test Water for Injection (WFI) and purified water samples.
• Manage stability study testing and retain sample lifecycle.
• Prepare and maintain microbiology media, test reagents, and reference cultures.
• Maintain cleanroom integrity, lab equipment, and support environmental/viable monitoring.
• Document test records per GDP and ALCOA+ principles.
• Escalate invalid, OOS/OOT, or atypical results and assist with root-cause investigations.

Responsibilities

• Perform BET, Sterility Testing, and MLT using validated aseptic methods.
• Water & utility monitoring: test WFI, Purified Water, and process samples.
• Stability study testing and retain sample lifecycle management.
• Media & culture control: prepare media, reagents, and reference cultures.
• Maintain GDP/ALCOA+ documentation and logbooks.
• Deviations & investigations: assist with root-cause analysis.

Job description

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 Good Documentation Practices (GDP) and ALCOA+ principles.
• Deviations & Investigations: Escalates invalid, OOS/OOT, or atypical results immediately and assist with root-cause investigations.