Vacancy: 01 Location: VAPI- GUJARAT Experience: 8 to 13 Years Qualification: B. Sc/ M. Sc- Micro/ Biotechnology with FDA Approval (Preference) Job Description: The ideal candidate will possess strong technical expertise in analytical instrumentation, regulatory compliance, and quality systems, with hands-on experience in RM, PM, and FG analysis. Key Responsibilities Analytical Operations Perform and supervise analysis of Raw Materials (RM), Packing Materials (PM), and Finished Goods (FG). Operate and maintain analytical instruments: o HPLC, GC, UV-Vis, FTIR, Dissolution Apparatus Ensure compliance with GLP, 21 CFR Part 11, and data integrity standards. Review and approve analytical reports and LIMS entries. Quality Systems & Compliance Implement and monitor Quality Management Systems (QMS). Lead investigations for OOS, OOT, Deviations, and Laboratory Incidents. Prepare and review SOPs, STPs, and validation protocols. Ensure audit readiness and support regulatory inspections (USFDA, WHO-GMP, etc.). Documentation & Reporting Maintain accurate documentation in LIMS and ensure traceability. Prepare investigation reports, CAPA, and trend analysis. Coordinate with cross-functional teams for timely release and compliance. Project & Team Leadership Mentor and train QC analysts on instrumentation and regulatory practices. Lead or contribute to method validation, tech transfer, and stability studies.
