QA Officer (Systems)

This role will see you join the Keele site QA team reporting to the QA Leader (Systems). You will be responsible for maintenance of the site supplier assurance program. Maintenance of the internal and external audit programmes including, performing internal Audits, writing of internal Audit reports and agreeing appropriate CAPA. The role will also include working with the other departments on site reviewing and approving site training modules and role out.

Key Responsibilities

• Participate in the preparation of Vendor Risk Assessments


• Track, Monitor, and Maintain Vendor Qualification and Re\-Qualification, and respective documentation


• Review Vendor Qualification Documentation and Vendor Change Notifications


• Maintain the Keele Approved Vendor List


• Review Vendor Past Performance


• Archive all Qualification Documentation and Agreements


• Maintenance of Internal and External audit programmes


• Perform internal audits to ensure standards are being maintained to on site SOP’s and regulatory requirements.


• Authoring internal audit reports


• QA representative to support internal training initiatives and role out


• Support Change Control, Deviation and CAPA management


• Review and approval of Material Specification Sheets

• Good communication, both verbal and written


• High levels attention to detail


• Enthusiasm to look for process improvement ideas


• Proficient in Microsoft Word and Excel, strong administration skills

• Understanding of GMP or other regulated environment


• Previous Supplier/vendor assurance experience


• Previous QA Experience


• Previous audit experience


• Knowledge of Sharepoint, Smartsheet and SAP

• Company pension


• Enhanced maternity leave


• Free flu jabs


• On\-site parking


• Private medical insurance

• United Kingdom (required)

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