Gxp Quality Support Officer
4 days ago
**Responsibilities section**: The job holder will be required to carry out the following responsibilities, activities and duties: Provide support to the GxP QA Team to ensure that the quality system meets appropriate regulatory requirements e.g., Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP). To assist in the transition to, implementation and maintenance of the GxP electronic Quality Management System (eQMS) by carrying out administration of all controlled documents and other workflows. Assist GxP eQMS Manager in the provision of support and the delivery of training to system users on the use of the GxP eQMS. Confidentially manage controlled documents which contain sensitive information.
To assist with the preparation of status reports (including KPI data) from the GxP Quality Management System. To provide administrative support to the GxP Quality Assurance department. To manage GxP QA spreadsheets, databases and the uploading of quality reports, technical agreements, and any other relevant quality documents. To provide support for customer audits and regulatory inspections.
Previous experience of working in an administrative environment using computerised data systems. Knowledge of Quality Management Systems administrative procedures or experience of working with GxP Quality Management Systems. Good working knowledge of Microsoft Office, including Word and Excel. Experience and knowledge of how to train others.
People working with government assets must complete Basic Personnel Security Standard checks. For posts on UKHSA Civil Service terms and conditions, new entrants to the Civil Service are expected to start on the minimum of the pay band. For existing Civil Servants and roles advertised across government, the rules of transfer apply, i.e., level transfers move on current salary or the pay range minimum, transfers on promotion move to new pay range minimum or receive a 10% increase. Either case is determined by whichever is the highest.
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