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auditing vendor management eu regulations gxp ich📋 Description
- Support GxP quality compliance activities.
- Oversee vendor qualification and audits; ensure compliance.
- Create and manage vendor audit schedules; conduct audits.
- Assist internal audits; maintain the internal audit program.
- Oversee inspection readiness and regulatory inspections.
- Collaborate cross-functionally to implement best practices.
🎯 Requirements
- Direct auditing experience required; CQA preferred.
- Bachelor’s in biological sciences; Master’s preferred.
- 5–7 years QA/GxP in pharma/biologics/advanced therapies.
- Strong knowledge of ICH, FDA, EU regulations.
- Team-oriented with strong organizational and communication skills.
- Willingness to travel.
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