Hiring : Qualification/Validation Executive for Cell and gene therapy at Zydus Biologics

Executive - Qualification/Validation (Pharma Engineering - QA) Reporting To: Section Head Department: Quality Assurance Section: Qualification/Validation (Pharma Engineering - QA) Location: Zydus Biologics, Biotech Park, Changodar, Ahmedabad Qualification: B. Pharm / M. Pharm / <M.Sc>. (Biotechnology or Microbiology) Experience: 1 to 3 years Key Responsibilities: Review and monitor equipment qualification activities for systems such as Autoclaves, Cold Rooms, Freezers, Bioreactors, Mixing Vessels, and other manufacturing equipment. Review and oversee utility qualification activities, including HVAC systems and Water Systems, along with the preparation, review, and compilation of qualification protocols and reports. Monitor and review calibration activities, preventive maintenance programs, Computer System Validation (CSV), and other engineering-related quality assurance activities. Prepare and review quality documents such as the Site Master File (SMF) and Validation Master Plan (VMP). Ensure compliance with regulatory requirements, cGMP guidelines, and internal quality standards in all qualification and validation activities. Candidate Requirements: Exposure to regulatory documentation requirements and cGMP practices is mandatory. Strong understanding of qualification, validation, calibration, and engineering quality systems within a pharmaceutical or biotechnology environment. Preferred Experience: Preference will be given to candidates who meet the above requirements and possess prior experience in: Cell and Gene Therapy (CGT) Biotechnology manufacturing facilities Injectable pharmaceutical manufacturing facilities