Senior Quality Assurance Expert

2 days ago

Sligo, Sligo, Ireland beBeeQuality Full time €100,000 - €120,000
Job Description

We are seeking a skilled Quality Assurance Specialist to join our team in Ireland. This role offers the opportunity to act as a subject matter expert across GMP and other GxP standards, driving supplier oversight, audits, and risk-based quality management.

As a Quality Assurance Specialist, you will play a key role in ensuring the highest quality standards across our global operations. You will be responsible for conducting audits, issuing reports, tracking CAPAs, verifying effectiveness, reviewing and approving supplier documents, assessing supplier quality systems versus global regulations, advising on procurement to ensure GxP compliance in supplier selection, and supporting teams in supplier investigations.

Key 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 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.
Required Skills and Qualifications

To be successful in this role, you should have a degree in Life Sciences, Pharmacy, Biotech, or a related field. You should also have 7–10 years' QA experience in pharma, biologics, or vaccines, with 5+ years hands-on in GxP supplier qualification & auditing (GMP + GLP/GCP/GDP). Strong knowledge of EU GMP, FDA, OECD GLP, VICH GCP & ICH guidelines is essential. Skilled in planning, conducting & reporting audits independently, deep understanding of quality systems, agreements & risk-based supplier qualification, experienced in investigations, CAPA management & change controls.

Benefits

This role offers excellent opportunities for career growth and professional development. As a member of our team, you will have access to training and mentorship programs, enabling you to stay up-to-date with industry best practices and advancements.

Why Choose Us?

Our company values its employees and provides a dynamic work environment that encourages collaboration, innovation, and continuous improvement. We offer competitive salaries, comprehensive benefits packages, and opportunities for advancement.

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