Quality control Officer/Executive

Job Description:

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.