Chief Quality Validation Specialist

2 weeks ago

Mumbai, Maharashtra, India beBeeCqV Full time ₹ 90,00,000 - ₹ 1,50,00,000

Job Title: Senior CQV Trainer

We are seeking a highly experienced CQV Engineer with over 10 years of proven expertise in Commissioning, Qualification, and Validation activities across the pharmaceutical and medical device sectors.

This role involves leading and executing CQV activities for manufacturing equipment, utilities, and computerized systems in compliance with regulatory and industry standards.

  • Lead and execute CQV activities for manufacturing equipment, utilities, and computerized systems.
  • Develop and review CQV documentation, including URS, DQ, FAT, SAT, IQ, OQ, PQ, and risk assessments.
  • Manage validation master plans and system impact assessments.

The ideal candidate will support global CQV projects remotely, ensuring compliance with FDA, EU, and other international regulations, including GxP standards.

Required qualifications include a Bachelor's or Master's degree in Engineering, Life Sciences, or a related field, and 10+ years of hands-on CQV experience in the pharma and/or medical device industries.

Key skills required include a deep understanding of regulatory requirements, expertise in GAMP 5, 21 CFR Part 11, and risk-based validation, as well as excellent communication and technical writing skills.

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