Job Description

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