Job responsibilities
The job holder will be required to carry out the following responsibilities, activities and duties:
- Assist in the delivery and maintenance of GxP training, QA documentation control, change control and risk assessment quality processes.
- Deliver GxP Training to meet quality, business and regulatory requirements.
- Liaise with stakeholders to ensure appropriate QA support is provided.
- Undertake assigned audits as part of the GxP internal audit programme including conducting QA reviews/ audits on study data, study records, GxP laboratories, supporting areas and critical suppliers of services and material.
- Contribute to writing key quality documents e.g. Quality Reports, Risk Assessments, Technical Agreements and Standard Operating Procedures etc.
- Undertake the review and approval of non-conformances, CAPA reports and related investigations, change controls and supplier approval questionnaires.
- Assist GxP Test Facilities areas, Test Facilities Management and the Quality Team in preparation for, and during customer audits and regulatory inspections.
- Perform any other duties required by the Line Manager commensurate with grade.
- Undertake work in accordance with the UKHSAs risk management systems, policies and procedures, applicable quality systems (including current GLP, GCP and GMP regulations), H&S Laboratory Precautions Handbook and site wide UKHSA policies and procedures.
- To fulfil the requirements of UKHSA Values and Behaviours 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 responsibilities and duties.
It is important through your application and Statement of Suitability of 1500 words that you give evidence and examples of proven experience of each of the following criteria:
Essential Criteria:
- Educated to degree level in a relevant subject (i.e. Biological Sciences) or equivalent level of experience of working at a similar level in specialist area
- Understanding of the Good Manufacturing Practice, Good Laboratory Practice and/or Good Clinical Practice regulations and experience of having worked to one or more of these regulations.
- Good knowledge and preferably practical familiarity with relevant laboratory techniques and safe working practices.
- Ability to analyse and interpret complex information, evaluate issues and recommend an appropriate course to line manager.
- Excellent computer literacy skills with good knowledge of MS office and ability to produce accurate documentation and manipulate and present information effectively.
- Ability to plan own work independently and within teams. Can work on own initiative and organize own workload, is self-motivated with a meticulous attention to detail
Desirable Criteria:
- Training/experience in Quality Management Systems relevant to this post (e.g. CAPA, change control, risk assessment, document control)
- Skills for communication on complex matters and difficult situations, requiring persuasion and influence. Ability to maintain good working relationships with colleagues.
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.
If you are successful at this stage, you will progress to an interview.
STAGE 2 INTERVIEW
This competition will involve an interview by video.
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:
- Changing and improving
- Making Effective Decisions
- Working together
- Communicating and influencing
Technical:
- Ability to perform & report findings from quality audits of laboratories, data and study reports.
- Knowledge of investigating and managing non-conformances and CAPA.
- Ability to provide face-to-face training as classroom sessions or workshops.
- Knowledge and understanding of working to GxP regulations.
Expected Timeline:
Advert close: 23:55hrs on 1st Jan 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: TBC
Interviews: w/c TBC
Please note these dates could be subject to change.
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.