Quality Specialist

Collins McNicholas

  • Sligo
  • Permanent
  • Full-time
  • 2 days ago
Excellent opportunity for a QA Specialist to join a newly created Vaccines company in Ireland. This role offers the opportunity to act as a QA subject matter expert across GMP and other GxP standards, driving supplier oversight, audits, and risk-based quality management. With deep knowledge of international regulations and proven expertise in supplier qualification, you will play a key role in ensuring the highest quality standards across their global operations.Overview of your responsibilities (full job description available on request)
  • Act as global QA SME for GxP supplier oversight (GMP, GLP, GCP, GDP).
  • Lead and improve supplier qualification programme (risk, audits, monitoring).
  • Conduct audits, issue reports, track CAPAs, verify effectiveness.
  • Review/approve supplier docs: 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.
Knowledge, Skills and Experience Required for the Role:
  • 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
For a confidential discussion and more information on the role contact Courtney Russell+353 (0) 71 9108062

Collins McNicholas