CQV Trainer Specialist

9 hours ago

Kanpur, Uttar Pradesh, India beBeeValidation Full time ₹ 19,19,180 - ₹ 23,17,083

Job Title: Senior CQV Trainer

About the Role

We are seeking a highly experienced and skilled professional to fill the position of Senior CQV Trainer. This role involves providing training and support to global teams, ensuring compliance with regulatory requirements and industry standards.

Main Responsibilities
  • Develop and execute comprehensive training programs for Commissioning, Qualification, and Validation activities.
  • Collaborate with cross-functional teams to ensure seamless integration into capital and remediation projects.
  • Conduct remote FAT/SAT support, data review, and validation strategy planning.
  • Drive continuous improvement and risk-based validation strategies in line with current industry best practices.
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, 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.
  • CQV experience in greenfield or brownfield capital projects.
  • Knowledge of Agile, Lean Six Sigma, or project management certifications (e.g., PMP).
Tools & Platforms
  • Veeva Vault, ValGenesis, TrackWise, Kneat Gx
  • Microsoft Office Suite, MS Project, SharePoint
  • Remote collaboration tools (MS Teams, Zoom, Slack)

This is an exciting opportunity to join our team as a Senior CQV Trainer and contribute to the success of our organization.

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