CQV Expert

1 week ago

Vadodara, Gujarat, India beBeeSenior Full time ₹ 90,00,000 - ₹ 1,20,00,000
Job Title: Senior CQV Trainer

We are seeking a skilled Senior Commissioning, Qualification and Validation (CQV) trainer with extensive experience in the pharma and medical device industries.

Key Responsibilities:
  • Lead and execute CQV activities for manufacturing equipment, utilities and computerized systems in compliance with regulatory standards.
  • Develop and review CQV documentation including URS, DQ, FAT, SAT, IQ, OQ, PQ and risk assessments.
  • Manage validation master plans and system impact assessments.
  • Collaborate with cross-functional teams to ensure seamless CQV integration into capital projects.
  • Conduct remote support and data review for validation test protocols.
Requirements:
  • Bachelor's or Master's degree in Engineering, Life Sciences or a related field.
  • 10+ years of hands-on CQV experience in the pharma and/or medical device industries.
  • Deep understanding of regulatory requirements (FDA, EU Annex 15, ICH Q8-10).
  • Expertise in GAMP 5, 21 CFR Part 11 and risk-based validation.

Tools & Platforms: Veeva Vault, ValGenesis, TrackWise, Kneat Gx, Microsoft Office Suite, MS Project, SharePoint, Remote collaboration tools (MS Teams, Zoom, Slack)