QA Specialist - Supplier & Vendor

https://www.teamhorizon.ie/1649-qa-specialist-supplier-vendor/quality/roscommon/job2025-09-04 16:34:052053-01-18Team Horizon
Job TypePermanent
AreaRoscommon, IrelandSligo, IrelandLeitrim, IrelandRoscommonIreland
SectorQuality
Start Date
AdvertiserAshling Guthrie
Job Ref3710
Job Views32
Description

Team Horizon is seeking a QA Specialist to join our client’s team on a permanent basis. In this role you will have responsibility for GxP Supplier and Vendor Oversight.


 


 


Why you should apply:



  • Opportunity to be part a diverse team and an established company which offer career progression opportunities.

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

  • Competitive salary & benefits package.


 


 


What you will be doing:



  • Act as the global QA SME for qualification and oversight of GxP-relevant suppliers, including GMP, GLP, GCP, GDP etc., service providers.

  • Lead the development, implementation, and continuous improvement of the supplier qualification program, including risk-based classification, audit planning, and ongoing performance monitoring.

  • Conduct supplier audits (initial, routine, for-cause), 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 (e.g., EMA, OECD GLP, VICH GCP, ISO/IEC 17025, HACCP, etc.).

  • Provide QA input into procurement decisions and cross-functional sourcing teams to ensure GxP compliance is considered in supplier selection.

  • Support internal stakeholders (e.g., R&D, Manufacturing, QC, Regulatory Affairs, Procurement) in supplier-related investigations and risk assessments.

  • Develop and deliver internal training on supplier qualification procedures and regulatory expectations.

  • Represent QA in cross-functional teams involving outsourced activities, ensuring the integrity of GxP-related data and deliverables.

  • Maintain accurate and current records in eQMS systems and supplier management databases.


 


What you need to apply:



  • 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.

  • 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%


 

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