Microbiology Lab Technician

4 weeks ago

Baddi, Himachal Pradesh, India ikon remedies 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 Job Type Full-time Pay 15 000 00 - 25 000 00 per month Work Location In person

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