Job responsibilities
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.
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.
Essential Criteria:
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.
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 athttps://www.gov.uk/government/publications/nationality-rulesThis 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 theEuropean 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&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/
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.
