Senior Quality Officer

6 months ago

Porton, United Kingdom UK Health Security Agency Full time

The job holder will be required to carry out the following responsibilities, activities and duties: Support the QA Team Leader in the provision of leadership and QA management for projects within the GxP Test Facility in compliance with the appropriate regulations, including Good Clinical Practice, Good Laboratory Practice, and current Good Manufacturing Practice. Take a lead role in ensuring appropriate quality standards are applied in the GxP Test Facility areas. Assist in ensuring the GxP Training system meets quality, business, and regulatory requirements. Take a lead role in maintaining and improving the quality management system (QMS).

Take a lead role in ensuring appropriate quality standards are applied in the GxP Test Facility areas and provide specialist GxP quality compliance advice to stakeholders. Take a lead role in setting up and executing an appropriate GxP internal audit programme. Conduct QA reviews/ audits on study data, study records, GxP laboratories, supporting areas and critical suppliers of services and materials. Write and review key quality documents e.g., Quality Reports, Quality Risk Assessments, Technical Agreements, Standard Operating Procedures and Policy documents etc.

Manage, review and approve non-conformances, CAPA reports and related investigations, change controls and supplier approval questionnaires. Provide a high level of support to GxP Test Facilities areas, Test Facilities Management, and the Quality Team in preparation for, and during customer audits and regulatory inspections. Line manage junior team members in the Quality Team. Perform any other duties required by the Line Manager commensurate with grade.

Experience of having worked within a regulated environment (GMP, GCP, GLP). Good knowledge and preferably practical familiarity of laboratory techniques. Good knowledge of GxP Data Integrity requirements. Experience in leading, conducting and reporting GxP audits.

Experience in developing/ managing/ maintaining Quality Management Systems relevant to this post (e.g. CAPA, change control, quality risk assessment, training, document control). Desirable Experience of leading projects and/or teams. Basic understanding of GxP equipment, computer systems and method validation requirements.

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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