Quality Assurance Expert

1 week ago

Galway, Galway, Ireland beBeeQualityAssurance Full time €75,000 - €105,000

Job Summary

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We are seeking a highly skilled Quality Assurance Specialist to join our organization. In this role, you will be responsible for overseeing the qualification and oversight of GxP suppliers.

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Key Responsibilities

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  • Act as the global QA SME for qualification and oversight of GxP-relevant suppliers, including GMP, GLP, GCP, GDP etc.">
  • Lead the development, implementation, and continuous improvement of the supplier qualification program.">
  • Conduct supplier audits, prepare audit reports, track CAPAs, and verify implementation effectiveness.">
  • Review and approve supplier quality documentation, such as Technical/Quality Agreements, audit responses, change notifications, and deviation reports.">
  • Evaluate supplier quality systems and compliance with applicable international regulatory requirements.">
  • Provide QA input into procurement decisions and cross-functional sourcing teams.">
  • Support internal stakeholders in supplier-related investigations and risk assessments.">
  • Maintain accurate and current records in eQMS systems and supplier management databases.">
  • Represent QA in cross-functional teams involving outsourced activities.">
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Requirements

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  • Bachelor's degree or higher in Life Sciences, Pharmacy, Biotechnology, or a related scientific discipline.">
  • Minimum of 7–10 years of QA experience in the pharmaceutical, biologics, or veterinary vaccine industry.">
  • At least 5 years of hands-on experience in GxP supplier qualification and auditing.">
  • Solid knowledge of EU GMP, FDA regulations, OECD GLP, VICH GCP, and ICH guidelines.">
  • Proven ability to plan, conduct, and report external audits independently.">
  • Strong understanding of quality systems, technical agreements, and risk-based approaches to supplier qualification.">
  • Critical thinking, strong attention to detail, and ability to interpret complex regulations into operational requirements.">
  • Excellent communication and interpersonal skills.">
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Benefits

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Competitive salary and benefits package.

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What We Offer

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Opportunity to be part of a diverse team and an established company offering career progression opportunities.

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They put their people first and live their diversity and inclusion values embracing all perspectives.

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Travel opportunity up to 25%.

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