Audits :
- Monitor and conduct internal and external audits, GcP experience required,
- Issue annual audit plan,
- Feed partners management by establishing robust KPI

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Suppliers
- Manage Quality Agreement, liaise with MSA
- Part of supplier selection, proactive in supplier qualification in case of urgent needs,

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Partners and Vendors:
- Support and develop Sponsor oversight culture,
- QA counterpart for partners (LianBio)

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Monitor our CMO partner from a QA perspective :
- Follow up reports and investigation,
- Quality agreement update, technical documentation related to the CE Mark,
- Support and contribute to specific SOP, such as Visual Inspection
- Manage gamma sterilization step

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Expertise in “external” QA in suppliers, vendors management,
Project oriented,
Sense of efficiency across kpi’s management,
Strong knowledge in reglementation, both in GMP and MDR
Qualified as “auditor”

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