
QA Specialist
3 weeks ago
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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