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Quality Assurance Systems Coordinator

3 months ago

Llantrisant, Rhondda Cynon Taf, United Kingdom Revvity Full time
Key Responsibilities
  • Internal Audit Coordination: Oversee the internal audit program, ensuring timely reviews of the audit schedule. Communicate with auditors in advance to facilitate preparation, assist internal auditors in organizing opening and closing meetings, and document findings in the SAP system post-approval from stakeholders.
  • SAP Document Management System Management: Facilitate the addition of new documents into the SAP DMS for review and approval. Ensure that PDF versions of new documents are accessible in the Quality Portal for relevant departments and conduct bi-weekly meetings with department leads to monitor progress.
  • Collaboration on CAPA System: Work closely with the Quality Engineer to add new Corrective and Preventive Actions (CAPA) to SAP. Attend CAPA progress meetings, update actions and due dates, and document objective evidence during CAPA by attaching it to SAP Notifications. Ensure proper documentation of CAPA phases and update the Global CAPA tracker monthly. Engage with CAPA owners to verify sustainable progress and suitable evidence for audit reviews.
  • Deviation and Concession Management: Manage the approval process for new deviations via DocuSign and oversee the closure of deviations through the same platform. Maintain the Deviation and Concession Tracker to ensure accurate tracking.
  • Quality Portal Maintenance: Update the Quality Portal storage location for both open and closed deviations, ensuring all attachments are properly stored post-DocuSign.
  • Quality Management Review (QMR): Contribute to the QMR by populating the QMR Slide deck with inputs from department managers and assist in facilitating and presenting the QMR.