Quality Assurance Professional

3 days ago

Sligo, Sligo, Ireland beBeeSupplier Full time
Job Overview

The QA Specialist will play a crucial role in ensuring the quality of GxP-relevant suppliers and service providers. This position requires strong knowledge of EU GMP, FDA regulations, OECD GLP, VICH GCP, and ICH guidelines.

Key Responsibilities
  1. Act as the global QA SME for qualification and oversight of GxP-relevant suppliers, including GMP, GLP, GCP, GDP etc., service providers.
  2. Lead the development, implementation, and continuous improvement of the supplier qualification program, including risk-based classification, audit planning, and ongoing performance monitoring.
  3. Conduct supplier audits (initial, routine, for-cause), prepare audit reports, track CAPAs, and verify implementation effectiveness.
  4. Review and approve supplier quality documentation, such as Technical/Quality Agreements, audit responses, change notifications, and deviation reports.
  5. Evaluate supplier quality systems and compliance with applicable international regulatory requirements.
  6. Provide QA input into procurement decisions and cross-functional sourcing teams to ensure GxP compliance is considered in supplier selection.
  7. Support internal stakeholders in supplier-related investigations and risk assessments.
  8. Develop and deliver internal training on supplier qualification procedures and regulatory expectations.
  9. Represent QA in cross-functional teams involving outsourced activities, ensuring the integrity of GxP-related data and deliverables.
  10. Maintain accurate and current records in eQMS systems and supplier management databases.
Requirements
  • 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, with demonstrated expertise in GMP and at least one of the following: GLP, GCP, GDP.
  • Experience with laboratory testing, contract manufacturing, and/or clinical service providers preferred.
  • Proficiency in English (written and oral); additional languages are an asset.
Desirable Skills
  • 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.
  • Experience with quality investigations, CAPA management, and change control.
  • Proficiency with QMS tools, audit tracking systems, and MS Office; experience with eQMS platforms preferred.
  • Critical thinking, strong attention to detail, and ability to interpret complex regulations into operational requirements.
  • Excellent communication and interpersonal skills; capable of engaging with diverse stakeholders globally.
  • Willingness to travel domestically and internationally up to 25%
Benefits

We offer a competitive benefits package, including equal opportunities for all qualified applicants.

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