Microbiology Lab Technician

Key Responsibilities

1. Stability Study Management

• Execute stability studies as per ICH guidelines (Q1A–Q1E) and company protocols.
• Place, withdraw, and test samples from stability chambers (accelerated, intermediate, and long-term).
• Perform analysis of stability samples for physical, chemical, and microbiological parameters.
• Monitor and document environmental conditions of stability chambers.

2. Laboratory Operations

• Operate analytical instruments (HPLC, GC, UV, FTIR, Dissolution apparatus, etc.) for stability testing.
• Ensure proper calibration, qualification, and maintenance of instruments.
• Conduct method validation, method transfer, and analytical troubleshooting related to stability.

3. Documentation & Compliance

• Prepare and maintain stability protocols, data sheets, logbooks, and reports as per GDP.
• Prepare stability summary reports for regulatory submissions and internal review.
• Handle deviations, OOS (Out of Specification), and OOT (Out of Trend) results, and assist in investigation & CAPA implementation.
• Ensure compliance with cGMP, GLP, WHO, FDA, MHRA, and other regulatory requirements.

4. Audit & Regulatory Support

• Support internal audits, external inspections, and customer audits.
• Ensure compliance with data integrity principles (ALCOA+).
• Provide stability data to Regulatory Affairs, QA, and Product Development teams as required.

5. Safety & Continuous Improvement

• Follow EHS practices in the laboratory while handling chemicals and solvents.
• Support improvements in stability study designs to reduce cycle time.
• Participate in training, method improvement, and implementation of new technologies.

Qualifications & Skills

• Education: M.Sc. (Chemistry / Analytical Chemistry) / B.Pharm / M.Pharm
• Experience: 1-2 years in stability studies / QC stability section (pharma industry – OSD, injectables, or APIs).
• Good knowledge of ICH stability guidelines and regulatory expectations.
• Hands-on experience with HPLC, GC, UV, Dissolution, and other analytical instruments.
• Strong documentation and data integrity practices.
• Ability to analyze trends, identify OOT, and support investigations.
• Willingness to work in shifts if required.

Job Type: Full-time

Pay: ₹15,000.00 - ₹25,000.00 per month

Work Location: In person