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  • Sector: Engineering
  • Contact Email:
  • Job Ref: 21604

Excellent opportunity for a QA CQV Lead to join a global biologics leader in Ireland. As QA CQV Lead, you'll report directly to the QA Director and will be responsible for ensuring the quality and compliance of validation and equipment qualification activities. You will oversee computerized systems and lab equipment qualification, aligning with regulations, company policies, and contractual obligations. Your responsibilities will include reviewing and approving commissioning and qualification activities, providing essential guidance for equipment lifecycle documentation, participating in investigations, reviewing SOPs, and deviations, and collaborating on audits and regulatory inspections.

Overview of your responsibilities (full job description available on request):

  • Oversee validation and equipment qualification activities, ensuring compliance with regulations.
  • Review and approve commissioning and qualification activities throughout the validation lifecycle process.
  • Provide guidance for creating equipment lifecycle documentation.
  • Lead or support investigations related to qualification discrepancies.
  • Review and approve SOPs, deviations, and other key quality documents.

Knowledge, Skills and Experience Required for the Role:

  • Minimum of a bachelor’s degree in biology, biotechnology, or a relevant discipline.
  • Ideally 6 years of QA experience in the biotech/pharmaceutical industry, with preference given to those with vaccine or biologics experience.
  • Strong understanding of cGMP requirements, GAMP, and Part 11 compliance.
  • Excellent knowledge of validation principles and industry best practices.
  • Familiarity with audit challenges and regulatory inspections.

For a confidential discussion and more information on the role contact Courtney Russell

+353 (0) 71 9108062