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Civil Service Pension with an average employer contribution of 27%
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About the job
Job summary
At the United Kingdom Health Security Agency (UKHSA) our mission is to provide health security for the nation by protecting from infectious disease and external hazards. We are a trusted source of advice to government and to the public, focusing on reducing inequalities in the way different communities experience and are impacted by infectious disease, environmental hazards, and other threats to health.
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.*
Job description
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.
- Perform any other duties required by the Line Manager commensurate with grade.
The duties/responsibilities listed above describe the post as it is at present and is not intended to be exhaustive. The Job holder is expected to accept reasonable alterations and additional tasks of a similar level that may be necessary.
Person specification
It is important through your application and Statement of Suitability of 1000 words that you give evidence and examples of proven experience of each of the following criteria:
Essential
- Educated to MSc and several years experience or Degree and substantial relevant experience (in relevant subject area).
- 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).
- Ability to analyse and interpret information, pre-empt and evaluate issues, and recommend and appropriate course of action.
- Problem solving skills and ability to respond to sudden unexpected demands.
Desirable
- Experience of leading projects and/or teams.
- Basic understanding of GxP equipment, computer systems and method validation requirements.
Benefits
£27 towards you being a member of the Civil Service Defined Benefit Pension scheme.
Find out what benefits a Civil Service Pension provides.
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
Things you need to know
Selection process details
STAGE 1 – APPLICATION & SIFT:
You will be required to complete an application form. This will be assessed in line with the advertised essential criteria please do provide evidence of how you meet this.
Your Statement of Suitability (max 1000 words) should outline your skills, experience, and achievements, providing evidence of your suitability for the role, with reference to the essential criteria (outlined in the person specification section).
**Please do not submit your CV, we require you to complete the full application process including a Personal Statement/Statement of Suitability, as outlined below. Please ensure that your Statement of Suitability contains no personal identifiers e.g. name in either the file name or content of the document.**
You will also be asked to provide information within the Employer/Activity history section of the application form. This is equivalent to the information you would provide on a CV, setting out your career history.
If you are successful at this stage, you will progress to an interview.
STAGE 2 INTERVIEW
As part of the process, candidates will be invited to interview which will involve an in-depth discussion of your previous experience and professional competence using the Success Profiles framework.
The Behaviours tested during the interview stage will be:
Expected Timeline:
Advert close: 23:55hrs on 5th October 2023 unfortunately, late applications will not be considered. Once this job has closed, the job advert will no longer be available. You may want to save a copy for your records.
Interviews: W/C 23d October 2023
Please note these dates could be subject to change.
We recruit by merit on the basis of fair and open competition, as outlined in the Civil Service Commission’s Recruitment Principles.
The Civil Service embraces diversity and promotes equal opportunities. As such, we run a Disability Confident Scheme (DCS) for candidates with disabilities who meet the minimum selection criteria.
The Civil Service welcomes applications from people who have recently left prison or have an unspent conviction. Read more about prison leaver recruitment.
Security clearance level requirement
Successful candidates must pass a disclosure and barring security check. Successful candidates must meet the security requirements before they can be appointed. The level of security needed is Basic Personnel Security Standard.
A basic check is required.
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.
Please Note
This role is to be appointed under Civil Service Terms & Conditions. Full details on the T&Cs are found https://www.ukhsa.reed.com/
Are you already a civil servant, or employed by a Civil Service Commission accredited public body? Please state home department on your application form.
Do you meet the nationality requirements for this post? https://www.ukhsa.reed.com/
The law requires that selection for appointment to the Civil Service is on merit on the basis of fair and open competition as outlined in the Civil Service Commission’s Recruitment Principles. If you feel your application has not been treated in accordance with the Recruitment Principles, and you wish to make a complaint, in the first instance, you should contact UKHSA Public Accountability Unit via email: Complaints1@ukhsa.gov.uk. If you are not satisfied with the response you receive from the Department, you can contact the Civil Service Commission: Visit the Civil Service Commission website.
Feedback will only be provided if you attend an interview or assessment.
Security
Nationality requirements
Working for the Civil Service
We recruit by merit on the basis of fair and open competition, as outlined in the Civil Service Commission’s recruitment principles (opens in a new window).
Apply and further information
You may want to save a copy for your records.
Contact point for applicants
Job contact :
- Name : Nicoleta Enciu
- Email : UKHSA.Recruitment@reed.com
Recruitment team
- Email : UKHSA.Recruitment@reed.com
