Senior Pharmaceutical Validation Specialist

2 weeks ago

Anand, Gujarat, India beBeeCqvaluation Full time ₹ 16,00,000 - ₹ 20,80,000

Job Title: Senior Commissioning, Qualification, and Validation Professional

Our organization is seeking a highly experienced Senior CQV professional with over 10 years of proven expertise in Commissioning, Qualification, and Validation activities. The ideal candidate will support global CQV projects remotely, ensuring compliance with FDA, EU, and other international regulations, including GxP standards.

  • Lead and execute CQV activities for manufacturing equipment, utilities, and computerized systems in compliance with regulatory and industry standards.
  • Develop and review CQV documentation, manage validation master plans, and system impact assessments.
  • Collaborate with cross-functional teams to ensure seamless CQV integration into capital and remediation projects.
  • Conduct remote FAT/SAT support, data review, and validation strategy planning.
  • Support Data Integrity assessments and 21 CFR Part 11 compliance for computerized systems.
  • Ensure documentation complies with GAMP 5, FDA, EMA, and ISO 13485 requirements.
  • Mentor junior CQV professionals and act as a subject matter expert (SME) in audits and inspections.

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 (FDA, EU Annex 15, ICH Q8-10, ISO 13485).
  • Expertise in GAMP 5, 21 CFR Part 11, and risk-based validation.
  • Experience working in remote project environments.
  • Proficient in using validation lifecycle software and document management systems.

Preferred Skills and Qualifications:

  • Experience with sterile manufacturing, biologics, cell/gene therapy, or combination products.
  • CQV experience in greenfield or brownfield capital projects.
  • Knowledge of Agile, Lean Six Sigma, or project management certifications (e.g., PMP).
  • Prior experience working with global, cross-cultural teams remotely.

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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