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Job Location | Macclesfield |
Education | Not Mentioned |
Salary | Competitive salary |
Industry | Not Mentioned |
Functional Area | Not Mentioned |
Job Type | Contract, full-time |
Senior Quality Supplier Manager - 12 Month Secondment / Fixed Term Contract / Fixed Term Opportunity Location: UK (Macclesfield) or Sweden (Gärtuna)At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because an opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential.The Global Supplier Quality (GSQ) organisation leads Supplier Quality oversight for externally sourced materials to ensure that they align with the AstraZeneca Quality Standard, are safe and effective and meet the required regulatory standards. We do this through execution of the key Pharmaceutical Quality System (PQS) and supplier management business processes, by experienced and qualified Quality Professionals.GSQ provides Quality oversight globally for approximately 1,600 supplier sites in AstraZeneca Operations. The scope of the organization includes outsourced API, Biologics CMOs, Direct Materials including Devices, Formulation and Packing CMOs, Critical General Services, Contract Laboratories, Certification of Materials and the global IT System for Supplier Management.The Senior Quality Supplier Manager (SQSM) is a diverse and exciting role, working with Suppliers, Contractors and a broad range of AstraZeneca sites and functions. You will collaborate with colleagues and customers across many countries and interact cross-functionally with supply chain, supplier relationship, technical and project roles. Some travel may be required along with significant independence for the role. What youll do You will be responsible for assuring the quality of materials received by AstraZeneca from the designated supplier portfolio and will proactively ensure GMP and regulatory compliance during supplier related projects.You will be accountable for the Quality System oversight of Supplier related product quality complaints, change controls, deviation investigations, issue management and escalation, and Quality Agreements between AstraZeneca and External Suppliers; and the preparation and submission of Supplier Quality Risk Assessments, and support to Regulatory Agency inspections of supplier sites and site transfers.You will drive quality improvements at the supplier as part of a cross functional team.This role will also include the quality review and approval of Chemistry and Manufacturing Control (CMC) documents associated with changes or product establishment at suppliers. Key is building and maintaining a high level of understanding of relevant production processes and quality systems. Essential skills: