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

About this role

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What you'll do

• 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.

Who can apply

• Reporting To: Section Head
• Department: Quality Assurance
• Section: Qualification/Validation (Pharma Engineering - QA)
• Location: Zydus Biologics, Biotech Park, Changodar, Ahmedabad

About Zydus

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