Quality Assurance Expertise
We seek a Quality Assurance expert to drive supplier oversight, audits, and risk-based quality management in the Vaccines industry.
Key Responsibilities:
1. Lead GxP supplier oversight (GMP, GLP, GCP, GDP) for global QA teams.
2. Develop and improve supplier qualification programs (risk assessments, audits, monitoring).
3. Conduct supplier audits, issue reports, track corrective actions, and verify their effectiveness.
4. Review and approve supplier documents: agreements, responses, changes, deviations.
5. Evaluate supplier quality systems against international regulations (EMA, OECD GLP, VICH GCP, ISO, HACCP).
6. Advise on procurement to ensure GxP compliance in supplier selection.
7. Support cross-functional teams (R&D, QC, Regulatory, Procurement) in supplier investigations.
8. Promote internal training on supplier qualification.
Requirements:
* Bachelor's degree in Life Sciences, Pharmacy, Biotech, or related field.
* 7-10 years of experience in QA, preferably in pharma, biologics, or vaccines.
* 5+ years of hands-on experience in GxP supplier qualification and auditing (GMP + GLP/GCP/GDP).
* Bonus: experience with laboratories, contract manufacturers, or clinical service providers.
* Strong knowledge of EU GMP, FDA, OECD GLP, VICH GCP, and ICH guidelines.
* Skilled in planning, conducting, and reporting audits independently.
* Deep understanding of quality systems, agreements, and risk-based supplier qualification.
* Experienced in investigations, CAPA management, and change controls.