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2 weeks ago
As a microbiology laboratory specialist, you will play a pivotal role in maintaining the integrity and quality of our pharmaceutical products.
About the Role:- Stability Study Management: Execute stability studies as per ICH guidelines Q1A-Q1E and company protocols. Place, withdraw, and test samples from stability chambers, including accelerated, intermediate, and long-term conditions.
- Laboratory Operations: Operate analytical instruments such as HPLC, GC, UV, FTIR, dissolution apparatus, etc., for stability testing. Ensure proper calibration, qualification, and maintenance of instruments.
- 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.
- Audit & Regulatory Support: Support internal audits, external inspections, and customer audits. Ensure compliance with data integrity principles ALCOA.
- Safety & Continuous Improvement: Follow EHS practices in the laboratory while handling chemicals and solvents. Support improvements in stability study designs to reduce cycle time.
- Education: M.Sc. in Chemistry or Analytical Chemistry; B.Pharm., M.Pharm.
- Experience: 1-2 years in stability studies, QC stability section, pharma industry - OSD, injectables, or APIs.
- Skills: Good knowledge of ICH stability guidelines and regulatory expectations; hands-on experience with HPLC, GC, UV, dissolution, and other analytical instruments.
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