Validation Expert

3 days ago

Pune, Maharashtra, India beBeeCompliance Full time ₹ 1,60,00,000 - ₹ 2,20,00,000
Job Title: Senior CQV Trainer

We are seeking a highly experienced Senior Commissioning, Qualification and Validation (CQV) professional with over 10 years of proven expertise in the pharmaceutical and medical device sectors. The ideal candidate will support global projects remotely, ensuring compliance with international regulations, including GxP standards.

Key Responsibilities:
  • Lead and execute CQV activities for manufacturing equipment, utilities (e.g., HVAC, WFI, clean steam), 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 (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 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.
  • Mentor junior engineers and act as a subject matter expert (SME) in audits and inspections.

Required Skills and Qualifications:
  • Bachelor's or Master's degree in Engineering, Life Sciences, or a related field.
  • 10+ years of hands-on 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 environments.
  • Proficient in using lifecycle software and document management systems.
  • Excellent communication and technical writing skills.

Benefits:

This is an excellent opportunity to work with a talented team of professionals in a dynamic and fast-paced environment.


Others:

Validating your talents and leadership abilities is our top priority.

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