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UK Health Security Agency

About

The UK Health Security Agency (UKHSA) will be responsible for planning, preventing and responding to external health threats, and providing intellectual, scientific and operational leadership at national and local level, as well as on the global stage. UKHSA will ensure the nation can respond quickly and at greater scale to deal with pandemics and future threats.

Contact

Address: 10 South Colonnade; London; E14 4PU

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Closed

Ref: UKHSA00392 Vacancy ID: 5915806

GxP Quality Officer

Closed for applications on: 3-Jan-2024 00:02

Vacancy status: Closed

Closed for applications on: 3-Jan-2024 00:02

Location

Site: Porton Down
Town: Porton Down, Sailsbury
Postcode: SP4 0JG
Major / Minor Region: London

Contract type & working pattern

Contract

Fixed term: 12 months (Up Until 31 Mar 2025)

Hours

Full time
Flexible working

37.5 hours per week

Salary

Salary: £30,473 - £37,215 Per Anumn
Salary period: Yearly
Grade: (HEO)

Specialty

Main area: Science

The United Kingdom Health Security Agency (UKHSA) is a system leader for health security; taking action internationally to strengthen global health security, providing trusted advice to government and the public and reducing inequalities in the way different communities experience and are impacted by infectious disease, environmental hazards, and other threats to health.

UKHSA’s remit, as an agency with a global-to-local reach, is to protect the health of the nation from infectious diseases and other external threats to health. As the nation’s expert national health security agency UKHSA will:

Prevent: anticipate threats to health and help build the nation’s readiness, defences and health security
Detect: use cutting edge environmental and biological surveillance to proactively detect and monitor infectious diseases and threats to health
Analyse: use world-class science and data analytics to assess and continually monitor threats to health, identifying how best to control and mitigate the risks
Respond: take rapid, collaborative and effective actions nationally and locally to mitigate threats to health when they materialise
Lead: lead strong and sustainable global, national, regional and local partnerships designed to save lives, protect the nation from public health threats and reduce inequalities.

Detailed job description and main 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 UKHSA’s 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&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: [email protected]. 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.

IMPORTANT - PLEASE READ

Your application may be rejected and/or you may be subject to disciplinary action if evidence of plagiarism is detected. Examples of plagiarism can include presenting the ideas and experience of others, or generated by artificial intelligence (AI), as your own.

This is a Non-Reserved post under the Civil Service Nationality Rules. To be eligible for employment in the UK Civil Service applicants must meet the Civil Service Nationality Rules (CSNRs) which operate independently of and additionally to the Immigration Rules. Applicants must also meet necessary security and vetting requirements, along with any other relevant pre-employment checks.

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

For more information on job nationality requirements and the right to work in the UK, see the Civil Service Nationality rules (opens in a new window) and the UK Visas and Immigration rules (opens in a new window)

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.

The Civil Service pay structure and progression is different from NHS Agenda for Change (AfC), most local authority pay grades and other systems that have annual pay increments. For further details, please refer to the Information Sheet- Starting Salaries & Benefits attachment.

For AfC or Medical/Dental posts, you must have the correct professional registration to be appointed. The pay will follow the AfC or Medical & Dental terms & conditions. You may be asked to provide evidence of previous service whilst we are conducting pre-employment checks to determine your starting salary.

For Temporary Appointments, if you are not currently a civil servant, you will take up the post on a Fixed Term appointment.  You may be able to take this role up as a Secondment. If you are an existing Civil Servant, based outside of the UKHSA, you will take up the post as a loan which you will need your department to agree. You cannot take the post up as a fixed term. If you are an existing UKHSA member of staff, you will take up the post as either a level transfer or a temporary promotion as per the UKHSA’s Pay policy. 

Given the nature of the work of the UKHSA, as a Category 1 responder under the Civil Contingencies Act, you may be required in an emergency, if deemed a necessity, to redeploy to another role at short notice. You may also be required to work at any other location, within reasonable travelling distance of your permanent home address, in line with the provisions set out in your contract of employment.

Late Applications will unfortunately not be considered.

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 equality of opportunity. 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:  [email protected] 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 here.

Reserve List - If more than the required number of suitable candidates pass the interview criteria, you may be kept on a reserve list for 12 months subject to your agreement. You may be contacted, in merit-order, if similar roles with closely matching essential criteria become available and the department choose to appoint from a reserve list.

The panel will assess if candidates meet the requirement of the role first, using a specific benchmark system. If you are interviewed for the post and do not meet the required threshold for the specified grade, your application may be assessed against a similar, lower grade role and you may be offered the post should one be available.

Interview expenses will not be reimbursed.

UKHSA is required to check employment and/or education history covering three consecutive years. Please ensure you give details of at least two different referees, even if you were employed in one company for three years or more.

If you are offered a job, information will also be transferred into the national NHS Electronic Staff Records system. Please note, all communication regarding your application will be made via email, please ensure you check your junk/spam folders as emails are sometimes filtered there.

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 https://www.childcarechoices.gov.uk/.

 Benefits of working at UKHSA include:

Generous annual leave:
-26 days for the first 5 years of continuous service
-28 days after 5 years of continuous service
-32 days after 10 years of continuous service
-Plus public holidays and one privilege day for the King’s birthday
Access to a generous Defined Benefit pension scheme with employer contributions.
Access to a cycle-to-work salary sacrifice scheme, season ticket advances and payroll giving.
Access to a retail discounts and cashback site.
We also promote flexible working patterns (part-time, job-share, condensed hours). UKHSA views flexible working as essential in enabling us to recruit and retain talented people, ensuring that they are able to enjoy a long-lasting career with us. All employees have the right to apply for flexible working and there are a range of options available including working from home, compressed hours and job sharing.
We also offer a generous maternity/ paternity and adoption leave package.

Hybrid Working

UKHSA operates a hybrid working model where business needs allow. This provides us with greater flexibility about how and where we work, to get the best from our workforce.

As a hybrid worker, you will usually spend a minimum of 60% of your contracted hours (averaged over a month) working at one of UKHSA's locations (approximately 3 days a week pro rata) and the rest of your time working from home.

Disability Confident Scheme

The Civil Service embraces diversity and promotes equal opportunities. As such, we run a Disability Confident Scheme for candidates with disabilities who meet the minimum selection criteria at sift to ensure these candidates are invited to interview.   If you wish to be included in this scheme please tick the box on your application form.

Reasonable Adjustments

The Civil Service is committed to making sure that our selection methods are fair to everyone.

To help you during the recruitment process, we will take into account any reasonable adjustments that could help you.

An adjustment is a change to the recruitment process or an adjustment at work.

This is separate to the Disability Confident Scheme.

If you need an adjustment to be made at any point during the recruitment process you should:

Contact the recruitment team in confidence as soon as possible to discuss your needs.

You can find out more information about reasonable adjustments across the Civil Service here: https://www.civil-service-careers.gov.uk/reasonable-adjustments/

International Police Check

If you have spent more than 6 months abroad over the last 3 years you may need an International Police Check. This would not necessarily have to be in a single block, and could be time accrued over that period.

Internal Fraud check

If successful for this role as one aspect of pre-employment screening, applicant’s personal details – name, national insurance number and date of birth - will be checked against the Cabinet Office Internal Fraud Hub and anyone included on the database will be refused employment unless they can show exceptional circumstances. Currently this is only for External candidates to the Civil Service.

Security Vetting

Please check the Security Clearance needed for the role and follow the link for more information:

https://www.gov.uk/government/publications/united-kingdom-security-vetting-clearance-levels/national-security-vetting-clearance-levels

Applicant requirements

The postholder will have access to vulnerable people in the course of their normal duties and as such this post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service to check for any previous criminal convictions.

Person specification

Essential

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.