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2 days ago
We are seeking a highly skilled QA specialist to join our team in ensuring quality excellence across a global network of partners.
Key Responsibilities:- Lead supplier qualification and monitoring programs across GxP areas (GMP, GLP, GCP, GDP).
- Conduct supplier audits (initial, routine, and for-cause), prepare reports, and oversee CAPA effectiveness.
- Review and approve supplier quality documentation (agreements, deviations, change controls).
- Assess supplier systems against EU, FDA, OECD, ICH, and other global standards.
- Provide QA support to cross-functional teams and procurement decisions.
- Deliver internal training on supplier qualification and compliance expectations.
- Represent QA on outsourced projects to safeguard GxP data integrity.
- Maintain supplier records in eQMS and quality systems.
- Degree in Life Sciences, Pharmacy, Biotechnology, or related discipline.
- 7–10 years' QA experience within pharma, biologics, or vaccines.
- Minimum 5 years in supplier qualification & auditing (GMP expertise required; additional GLP/GCP/GDP an advantage).
- Strong knowledge of international GxP regulations and quality systems.
- Experienced in audits, CAPA, and change control.
- Excellent communication and stakeholder engagement skills.
- Fluent English (other languages desirable).
- Willingness to travel internationally (up to 25%).
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