Senior Validation Specialist

3 days ago

Jaipur, Rajasthan, India beBeeCqvEngineer Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

We are seeking an experienced Senior CQV Engineer to support global CQV projects remotely.

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 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.
  • Oversee remote execution of validation test protocols, ensuring deviations are captured and resolved.

Our ideal candidate will have a deep understanding of regulatory requirements and expertise in GAMP 5, 21 CFR Part 11, and risk-based validation.

Required 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.
  • Expertise in GAMP 5, 21 CFR Part 11, and risk-based validation.
  • Experience working in remote project environments.
Benefits:
  • Ability to work with global, cross-cultural teams remotely.
  • Opportunity to drive continuous improvement and risk-based validation strategies in line with current industry best practices.

The successful candidate will be proficient in using validation lifecycle software and document management systems.

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