
Vaccines Quality Specialist
2 days ago
An exciting opportunity for a quality assurance specialist to excel in a newly established vaccines company in Ireland.
This role offers the chance to serve as a QA subject matter expert across GMP and other GxP standards, driving supplier oversight, audits, and risk-based quality management.
Main Responsibilities:- Act as global QA SME for GxP supplier oversight (GMP, GLP, GCP, GDP).
- Lead and improve 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 regulations (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.
- 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.
Please contact Courtney Russell for a confidential discussion and more information on this role.
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