Leading Quality Assurance Expert
4 days ago
Job Opportunity:
">This is an exciting opportunity for a Quality Specialist to join our newly created Vaccines company in Ireland. As a quality subject matter expert across GMP and other GxP standards, you will drive supplier oversight, audits, and risk-based quality management.
">- 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.
Requirements
">- 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.
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