Your Key Responsibilities:
- Drafting of Annual Monitoring and Certification report for materials.
- Drafting and Archival of Quality Assurance Agreement with Suppliers/Service providers.
- Evaluation and Management of Supplier Change Notifications (SCN).
- Performing Quality Risk Assessment (QRA) for existing and new Suppliers/Service providers.
- Management of Supplier/Material qualification and supplier-related documentations.
- Preparation of regulatory statement for materials and finished products.
- Management and archival of Quality Questionnaires, QAA, QRA, and Compliance (ASL, Oversight monitoring) for Country Quality.
- Adherence to the current GxP and compliance requirements of Sandoz.
- Perform and deliver Quality Operations in support of product quality compliance and regulatory workflows.
- Support implementing service quality and process improvement projects, CAPA management within GQSI.
- Regularly communicate with customers and partners to collect feedback on support services and report deliverables.
- Hold accounts in workflow applications (such as SAP, GxQEM, CONDOR, ESOPs, TrackWise) to ensure appropriate execution of service deliverables.
- Intensify service-related GxP and non-GxP issues and ensure timely investigation and compliance with local and global operating procedures.
