Senior Validation Professional

7 days ago

Ghaziabad, Uttar Pradesh, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,50,00,000

We are seeking a highly skilled Senior Validation Trainer to join our team.

Key Responsibilities:
  • Lead and execute validation activities for equipment, utilities, and computerized systems in compliance with regulatory and industry standards.
  • Develop and review validation documentation including URS, DQ, FAT, SAT, IQ, OQ, PQ, and risk assessments (e.g., FMEA).
  • Manage and implement validation master plans (VMP) and system impact assessments.
  • Collaborate with cross-functional teams (engineering, QA, manufacturing, IT) to ensure seamless validation 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.
  • Oversee remote execution of validation test protocols, ensuring deviations are captured and resolved.
  • Drive continuous improvement and risk-based validation strategies in line with current industry best practices.
Required Qualifications:
  • Bachelor's or Master's degree in Engineering, Life Sciences, or a related field.
  • 10+ years of hands-on validation 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 Qualifications:
  • Experience with sterile manufacturing, biologics, cell/gene therapy, or combination products.
  • Validation 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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