Senior Quality Assurance Specialist

1 week ago

Sligo, Sligo, Ireland beBeeQuality Full time €90,000 - €120,000

Transforming Quality Across the Globe

We are seeking an experienced quality assurance specialist to play a key role in ensuring the highest quality standards across our global operations.

About the Role

  1. Act as global quality assurance subject matter expert for GxP supplier oversight (GMP, GLP, GCP, GDP)
  2. Lead and improve supplier qualification program
  3. Conduct audits, issue reports, track CAPAs, verify effectiveness
  4. Review and approve supplier documents: agreements, responses, changes, deviations
  5. Assess supplier quality systems vs global regulations (EMA, OECD GLP, VICH GCP, ISO, HACCP)
  6. Advise on procurement to ensure GxP compliance in supplier selection
  7. Support teams in supplier investigations
  8. Deliver internal training on supplier qualification

Requirements for Success

  • Degree in life sciences, pharmacy, biotech, or related field
  • 7-10 years' experience in QA in pharma, biologics, or vaccines
  • 5+ years hands-on in GxP supplier qualification & auditing (GMP + GLP/GLCP/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

Key Responsibilities:

Develop and implement quality policies, procedures and processes that meet regulatory requirements and drive business growth

Qualifications:

  • Proficiency in MS Office Suite
  • Experience with quality management software

What We Offer:

A competitive salary, comprehensive benefits package, and opportunities for professional growth and development

Why Choose Us:

Join a dynamic team of professionals dedicated to delivering exceptional quality and customer satisfaction

How to Apply:

Submit your resume and cover letter via email to [insert email]

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