Microbiology Lab Technician

5 days ago

Baddi, India ikon remedies pvt ltd Full time

**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.

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

Work Location: In person

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