Job Title
A key role has become available in our quality assurance team, specializing in the qualification and oversight of suppliers. This position is critical to ensuring compliance with relevant regulations and maintaining high-quality standards across our operations.
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Key Responsibilities
* Qualify and oversee GxP-relevant suppliers, including risk-based classification and audit planning.
* Conduct supplier audits, prepare audit reports, and track CAPAs for implementation effectiveness.
* Review and approve supplier quality documentation, such as Technical/Quality Agreements and audit responses.
Requirements
* Bachelor's degree or higher in a scientific discipline.
* Minimum 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.
Specialized Knowledge
* Solid knowledge of EU GMP, FDA regulations, OECD GLP, VICH GCP, and ICH guidelines.
* Proven ability to plan, conduct, and report external audits independently.