Senior Validation Specialist

2 weeks ago

Hubli, Karnataka, India beBeeCQV Full time ₹ 15,00,000 - ₹ 25,00,000
Senior CQV Specialist Position

The ideal candidate will be responsible for leading and executing Commissioning, Qualification, and Validation (CQV) activities across the pharmaceutical and medical device sectors.

This role involves ensuring compliance with FDA, EU, and other international regulations, including GxP standards, while managing and implementing validation master plans (VMP) and system impact assessments.

As a Senior CQV Specialist, you will collaborate with cross-functional teams to integrate CQV into capital and remediation projects, conduct remote FAT/SAT support, data review, and validation strategy planning, and ensure documentation complies with regulatory requirements.

Key Responsibilities:
  • Lead and execute CQV activities for manufacturing equipment, utilities, and computerized systems in compliance with regulatory and industry standards.
  • Develop and review CQV documentation, including URS, DQ, FAT, SAT, IQ, OQ, PQ, and risk assessments.
  • Manage and implement VMPs and system impact assessments.
  • Collaborate with cross-functional teams to ensure seamless CQV integration.
  • Conduct remote FAT/SAT support, data review, and validation strategy planning.
  • Ensure documentation complies with GAMP 5, FDA, EMA, and ISO 13485 requirements.

Required Skills and Qualifications:

  • 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, including FDA, EU Annex 15, ICH Q8-10, and ISO 13485.
  • Expertise in GAMP 5, 21 CFR Part 11, and risk-based validation.
  • Experience working in remote project environments.

Benefits:

  • Opportunity to work with global, cross-cultural teams remotely.
  • Prior experience working with Agile, Lean Six Sigma, or project management certifications is an asset.

Tools & Platforms:

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

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