Responsibilities for this role include:
1. Working in partnership with System and Sub System Owners to design, deploy, and maintain compliant, robust, aligned, lean, and efficient quality systems and tools at the site to support GMS and commercial strategy, and to support the product lifecycle.
2. Oversee the site data integrity program and act as system administrator for key Quality Systems e.g. Trackwise (ETS), Document Management System (VeevaVault), Learning Management System (LMS), Quality Master Data in SAP & ZLIMS.
3. Responsible for site Quality System Governance and Metrics (including Quality Council) and leading management reviews to ensure QSS consistently remain in place, in use and in control, comply with Global Quality Policies and Standards, and meet the most current regulatory requirements and best industry practices, to assure a compliant robust Quality system which is inspection ready.
4. Use quality risk management process to help monitor and control systems and to identify and prioritize areas for continual improvement of process performance and product quality throughout the product lifecycle and in compliance with ICHQ7.
5. Evaluation, approval & monitoring of suppliers including Quality Agreements (End to End Supplier Approval and Management).
6. Stewardship of the Change Control System with specific responsibility for management of regulatory changes and regulatory submissions.
7. Initiate and coordinate activities relating to regulatory submissions.
8. Support the QSS Lead with the site Inspection Readiness programme including internal, regulatory, and supplier inspection including management of supplier audits from planning to close out.
9. Quality reviewer of SOPs, LWIs, EOPs, Specifications, Protocols, Reports, CAPAs, etc.
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