Responsible for managing all quality aspects at external suppliers for External Supply QA / Chemical Operations and to ensure that the operational business is in compliance with cGMP, the Quality Assurance Agreement, regulatory requirements and the Novartis Pharma Quality Manual. Direct reporting line to the Head of Chemical Operations / ESO QA.
In Chemical Operations QA, the QAM has the following general tasks: Participate in the supplier qualification. Maintain and update documents related to the supplier. qualification (SOPs, SUQUOR). Participate in the supplier auditing program and in the respective follow-ups. Maintain and update documents related to the audits in AQWA and SAIS." Ensure that the annual goals of the team are met. Is the Novartis Single Point of Contact for all quality related activities at .the External Supplier. Ensure that all aspects of the handling, manufacturing and distribution of Chemical Operations products at the External Supplier are in compliance with the Novartis Pharma Quality Manual, the effective Quality Agreement, that they meet relevant cGMP regulatory requirements. Ensure that the External Supplier has implemented an adequate Quality System to support all QA activities. Manage all quality issues (complaints, recalls, change requests, counterfeits and product tampering, stability failures, annual product review etc.) according to the Quality Agreement and the Novartis Quality Manual. For contract manufacturers responsible for increased GMP overview (annual product review, major and critical deviations, assessment of quality trends and driving continuous improvement for processes and product quality performance. Work in the Supplier Relationship Team lead by the Supplier Relationship Manager to provide direction, formulate strategies and make decisions which ensure the efficient operation of the External Supplier business as a whole - Participation in the Business review of External suppliers