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

• Experience: 1+ year
• Seniority: Entry Level
• Education: Bachelor's degree required
• Languages: English