Job summary
This post is for a Senior Quality Officer in the GxP Quality Assurance Team. The post holder will be part of the independent Quality Assurance which provides support of GxP regulated test facilities.
The Senior Quality Officer role is a very varied and interesting role which involves the provision of functions such as maintaining essential elements of the GxP Quality Management System (including CAPA and non-conformance, quality risk assessment, change control, document control, supplier management etc.), delivery of a variety of training, a variety of audits (facility, support functions, data, process, critical study phases etc.), the review of validation and study documentation, providing compliance advice and the supervision and development of quality officers within the GxP Quality team.
This is a Fixed Term Contract with an end date on 31/03/2024.
Location
Porton Down, Salisbury, Wiltshire, SP4 0JG (on site)
*Please be aware that this role can only be worked from within the UK and not overseas. Relocation expenses are not available.*
Main duties of the job
The job holder will be required to carry out the following responsibilities, activities and duties:
- 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.
About us
Working for the UKHSA
For more information on the UKHSA please visit: UK Health Security Agency - GOV.UK (www.gov.uk)
Benefits
- Learning and development tailored to your role.
- An environment with flexible working options.
- A culture encouraging inclusion and diversity.
- A Civil Service pension with an average employer contribution of 27%.
- Range of health and wellbeing support.
- 26 days annual leave allowance increasing to 32 days after a 10-year service.
Any move to UKHSA from another employer will mean you can no longer access childcare vouchers. This includes moves between government departments. You may however be eligible for other government schemes, including Tax Free Childcare. Determine your eligibility at Childcare Choices | 30 Hours Free Childcare, Tax-Free Childcare and More | Help with Costs | GOV.UK
Details
Date posted
22 September 2023
Pay scheme
Other
Salary
£38,724 to £44,393 a year Senior Executive Officer
Contract
Fixed term
Duration
5 months
Working pattern
Full-time, Part-time, Job share, Flexible working
Reference number
UKHSA00434
Job locations
Porton Down
Salisbury, Wiltshire
SP4 0JG
Employer details
Employer name
UK Health Security Agency
Address
Porton Down
Salisbury, Wiltshire
SP4 0JG
Employer's website
https://www.gov.uk/government/organisations/uk-health-security-agency (Opens in a new tab)
Employer contact details
For questions about the job, contact:
Supporting documents
Privacy notice
UK Health Security Agency's privacy notice (opens in a new tab)