Expert Quality Assurance Specialist

4 days ago

Sligo, Sligo, Ireland beBeequality Full time €60,000 - €120,000
Quality Assurance Professional

This role presents an exceptional opportunity to serve as a Quality Assurance subject matter expert in the development of GMP and other GxP standards, overseeing suppliers, conducting audits, and implementing risk-based quality management. The ideal candidate will have deep knowledge of international regulations and proven expertise in supplier qualification, ensuring compliance with global operations.

Key Responsibilities
  • Global QA SME for GxP supplier oversight (GMP, GLP, GCP, GDP).
  • Lead and enhance supplier qualification program (risk, audits, monitoring).
  • Conduct audits, issue reports, track CAPAs, verify effectiveness.
  • Review/approve supplier documents: agreements, responses, changes, deviations.
  • Assess supplier quality systems vs global regs (EMA, OECD GLP, VICH GCP, ISO, HACCP).
  • Advise on procurement to ensure GxP compliance in supplier selection.
  • Support teams (R&D, QC, Regulatory, Procurement) in supplier investigations.
  • Deliver internal training on supplier qualification.
Required Skills and Qualifications
  • Degree in Life Sciences, Pharmacy, Biotech, or related field.
  • 7–10 years' QA experience in pharma, biologics, or vaccines.
  • 5+ years hands-on in GxP supplier qualification & auditing (GMP + GLP/GCP/GDP).
  • Bonus: experience with labs, contract manufacturing, or clinical service providers.
  • Strong knowledge of EU GMP, FDA, OECD GLP, VICH GCP & ICH guidelines.
  • Skilled in planning, conducting & reporting audits independently.
  • Deep understanding of quality systems, agreements & risk-based supplier qualification.
  • Experienced in investigations, CAPA management & change controls.

The successful candidate will be offered the opportunity to work in a dynamic environment, applying their expertise to drive quality excellence across our global operations. For confidential discussions and further information, please contact us directly.

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