About the job

Job summary

Senior Quality Officer

SEO National - £38,724 - £44,393

Based at UKHSA Porton Down – full-time on-site

Permanent Contract

 

Senior Quality Officer - GxP Quality Team

Are you looking for a challenging and rewarding role in quality assurance? Do you have a degree or equivalent experience in a relevant field and a solid knowledge of GxP regulations? If so, you might be the perfect candidate for the Senior Quality Officer position at UKHSA, Porton.

As a Senior Quality Officer, you will join the independent Quality Assurance function that supports the GxP regulated test facilities. You will work closely with the QA Team Leader to ensure the quality and compliance of projects within the GxP Test Facility, following the Good Clinical Practice, Good Laboratory Practice, and current Good Manufacturing Practice regulations.

Your main duties will include:

• Maintaining the GxP Quality Management System, including CAPA and non-conformance, quality risk assessment, change control, document control, supplier management, etc.
• Delivering training on quality and compliance topics to staff and stakeholders
• Conducting audits on facility, support functions, data, process, critical study phases, etc.
• Reviewing validation and study documentation for accuracy and completeness
• Providing compliance advice and guidance to project teams and management
• Supervising and developing quality officers within the GxP Quality team

This is a varied and interesting role that requires excellent communication, organisational, and problem-solving skills. You will also need to have a keen attention to detail, a proactive attitude, and a willingness to learn and improve.

 

Location

Based at UKHSA Porton Down – due to the nature of the post, you will be expected to be based on-site on a full-time basis

 

*Please be aware that this role can only be worked from within the UK and not overseas. Relocation expenses are not available.* 

 

Working Pattern – Full Time

Job description

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.

 

1. Take a lead role in ensuring appropriate quality standards are applied in the GxP Test Facility areas.
2. Assist in ensuring the GxP Training system meets quality, business, and regulatory requirements.
3. Take a lead role in maintaining and improving the quality management system (QMS).
4. 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.
5. 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.
6. Write and review key quality documents e.g., Quality Reports, Quality Risk Assessments, Technical Agreements, Standard Operating Procedures and Policy documents etc.
7. Manage, review and approve non-conformances, CAPA reports and related investigations, change controls and supplier approval questionnaires.
8. 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.
9. Line manage junior team members in the Quality Team.
10. 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.

Please see job description attached for full list of duties and competencies associated with the post.

Person specification

It is important through your application and Statement of Suitability of 1250 words that you give evidence and examples of proven experience of each of the essential criteria (for full details of all essential criteria please refer to the attached job description):

 

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).

 

Desirable

• Experience of leading projects and/or teams.
• Basic understanding of GxP equipment, computer systems and method validation requirements.

 

Please ensure that your statement of suitability does not contain any personal identifiers such as Name, Gender, Location, Marital Status, Sexual Orientation or Religion. The UKHSA operates a fair and open recruitment policy.

 

Benefits

Alongside your salary of £38,724, UK Health Security Agency contributes £10,455 towards you being a member of the Civil Service Defined Benefit Pension scheme. Find out what benefits a Civil Service Pension provides.

Things you need to know

Selection process details

Selection process details

STAGE 1 - APPLICATION & SIFT: 

You will be required to complete an application form. This will be assessed in line with the full list of essential criteria as detailed in the attached job description – please do provide evidence of how you meet this. 

If you are successful at this stage, you will progress to an interview.

STAGE 2 – INTERVIEW 

This competition will involve an in-person 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 in relation to the criteria set out in the Person Specification. 

Your Statement of Suitability 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).

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.

The Success Profiles framework will be used to assess and recruit the most suitable candidate.  The following behaviours will be used at the interview:

• Making Effective Decisions
• Communicating and Influencing
• Working Together
• Delivering at Pace

 

Expected Timeline:

Advert close: 23:55hrs on 25th February 2024 – 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.

Shortlist: 29th February 2024

Interviews: w/c 11th March 2024

Please note these dates could be subject to change.  

 

Eligibility Criteria

Open to all external applicants (anyone) from outside the Civil Service (including by definition internal applicants)

Nationality requirements

Appointments to roles within UKHSA will be made in accordance with the Civil Service nationality rules. These can be found at https://www.gov.uk/government/publications/nationality-rules This job is broadly open to the following groups:

• UK nationals
• Nationals of Commonwealth countries who have the right to work in the UK
• Nationals of the Republic of Ireland
• Nationals from the EU, EEA or Switzerland with settled or pre-settled status or who apply for either status by the deadline of the European Union Settlement Scheme (EUSS)
• Relevant EU, EEA, Swiss or Turkish nationals working in the Civil Service
• Relevant EU, EEA, Swiss or Turkish nationals who have built up the right to work in the Civil Service
• Certain family members of the relevant EU, EEA, Swiss or Turkish nationals

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.  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. 

Please Note

This role is to be appointed under Civil Service Terms & Conditions. Full details on the T&C’s 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/

Complaint process:

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

Successful candidates must undergo a criminal record check. People working with government assets must complete baseline personnel security standard (opens in new window) checks.

Nationality requirements

This job is broadly open to the following groups:

• UK nationals
• nationals of the Republic of Ireland
• nationals of Commonwealth countries who have the right to work in the UK
• nationals of the EU, Switzerland, Norway, Iceland or Liechtenstein and family members of those nationalities with settled or pre-settled status under the European Union Settlement Scheme (EUSS) (opens in a new window)
• nationals of the EU, Switzerland, Norway, Iceland or Liechtenstein and family members of those nationalities who have made a valid application for settled or pre-settled status under the European Union Settlement Scheme (EUSS)
• individuals with limited leave to remain or indefinite leave to remain who were eligible to apply for EUSS on or before 31 December 2020
• Turkish nationals, and certain family members of Turkish nationals, who have accrued the right to work in the Civil Service

Further information on nationality requirements (opens in a new window)

Working for the Civil Service

The Civil Service Code (opens in a new window) sets out the standards of behaviour expected of civil servants.

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). 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.