Pharmaceutical Validation Specialist

2 weeks ago

Guntur, Andhra Pradesh, India beBeeValidation Full time ₹ 60,00,000 - ₹ 80,00,000

This is a remote position requiring a skilled Pharmaceutical Validation Specialist to lead and execute CQV activities for manufacturing equipment, utilities, and computerized systems.

The ideal candidate will have 10+ years of hands-on experience in the pharma and/or medical device industries, with a deep understanding of regulatory requirements.

Key Responsibilities include:

  • Developing and reviewing CQV documentation including URS, DQ, FAT, SAT, IQ, OQ, PQ, and risk assessments
  • Managing validation master plans and system impact assessments
  • Collaborating with cross-functional teams to ensure seamless CQV integration into capital and remediation projects
  • Conducting remote FAT/SAT support, data review, and validation strategy planning

Required Qualifications include:

  • 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, 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

We are seeking a highly experienced individual to drive continuous improvement and risk-based validation strategies in line with current industry best practices.

We offer a unique opportunity for professional growth and development in a dynamic and fast-paced environment.

This role requires strong analytical, problem-solving, and communication skills, as well as the ability to work effectively in a team environment.

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