Quality Specialist, Sligo

Overview

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. Responsibilities

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

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 Contact email:

+353 (0) 71 9108062

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