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PRINCIPAL RESPONSIBILITIES:
1. Document assessments of the quality systems for supply chain API, drug products, raw materials, components, packaging materials by means of on-site audits, questionnaires, or other tools.
2. During these assessments the manufacturing processes of these materials will be evaluated and the reliability of executed tests and of data to be provided by the supplier will be judged
3. Monitor the quality parameters for the suppliers and report their performance on regular basis.Evaluation of reported changes and define corrective actions if applicable including new qualifications.
4. Assess the impact of reported quality deviations and changes on the status of the suppliers and linked materials and coordinate the required corrective actions. This can be lead to the selection and qualification of new suppliers in cooperation with other departments.
5. Involvement in change management, risk assessment, deviations, escalations, compliance issues, recalls, field actions that are related to suppliers and the material they supply and/or external manufacturers of APIs and intermediates where applicable
6. Establishment and periodic review of Quality Agreements
7. Establishment and revision of Qualification Statements, periodic performance metrics, and qualification classification for suppliers.
8. Help in preparation for and during health authority inspections at sites or suppliers, as needed.
9. Participate in partnership or improvement projects.