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About the job
Job summary
We have an exciting opportunity for a Regulatory Compliance Officer to support the Quality and Assay Performance and Compliance Unit (APCU) in Reference Laboratories Colindale. You will be working with Quality Implementation and Compliance Manager, Regulatory Compliance Manager, Operations Team and Technical Managers in complying with regulatory affairs, achieving, and maintaining high quality performance and supporting continual improvement in service delivery in all processes in accordance with UKHSA policies and procedures.
In collaboration with the Reference Laboratories Colindale Quality Implementation and Compliance Manager and Regulatory Compliance Manager to become familiar with the area of work for which they are Regulatory Compliance Officer and be familiar with relevant statutory requirements, including awareness of regulatory acts, clinical governance, risk management, Caldicott and quality policies and procedures of Reference Laboratories Colindale at Colindale and the system(s) of accreditation in use.
This role will be based at our Colindale office (61 Colindale Avenue, London, NW9 5EQ), some hybrid working may be available subject to manager approval and business needs.
*Please be aware that this role can only be worked from within the UK and not overseas. Relocation expenses are not available.*
Job description
- To ensure that Reference Laboratories – Colindale comply with, IVD regulations, relevant ISO and other accreditation standards in collaboration with the IVD Programme Core Team, Quality team, Regulatory Compliance Manager and other staff
- To take delegated regulatory and quality management tasks from the Quality Implementation and Compliance Manager and Regulatory Compliance Manager
- Work with others to fulfil the regulatory and quality related responsibilities and functions of the laboratories or units that the post holder is assigned to
- Provide practical support for preparation for and organisation of inspections by third party assessors, such as UKAS, HSE and WHO assessors and to progress issues arising from these inspections
- Assist laboratory Quality Team and Quality Implementation and Compliance Manager to ensure compliance with IVDR Regulations
- Carry out regular internal audits and ensure that investigations and corrective actions are addressed in a timely manner.
- To assist the notification of adverse incidents on the Governance Information System (Trackwise), and support the investigation and resolution of incidents
- To support for the continuous improvement in service delivery and quality compliance within all areas of Reference Laboratories Colindale, using modern methods in ensuring the highest standards of quality, regulatory and process control.
- To collaborate with the Quality Team and Assay Performance and Compliance Unit (APCU) Team within UKHSA Colindale, attending required meetings as required
- To implement the measuring and monitoring of key process indicators within the laboratory
- Assist laboratory staff to comply with applicable regulatory and quality standards
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 750 words that you give evidence and examples of proven experience of each of the following criteria:
Essential
- Science degree or equivalent in microbiology or a related pathology discipline
- Evidence of continuing professional development and willingness to continue the learning process through academic or practical experience
- Substantial laboratory experience working in an accredited medical laboratory
- Experience in applying a range of standards, regulations and guidelines applicable to clinical laboratories
- Understanding of IVD governance principles and procedures
- Understanding and experience of change management and experience of implementing projects
- Sound knowledge of common IT programmes, including Q Pulse and excellent keyboard and IT skills.
- Excellent verbal and written communication, data analysis, statistical skills and the ability to work on own initiative and as part of a team
- Excellent interpersonal, negotiating, and organisational skills, self-motivated, analytical and adaptable
Desirable
- Quality management qualification and knowledge of Regulatory compliance
- An understanding of microbiology and its application in clinical practice and public health
Benefits
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
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.
If you are successful at this stage, you will progress to an interview.
STAGE 2 INTERVIEW
The interviews will be held in person at our Colindale office.
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 (750 words max) 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:
- Seeing the big picture, Changing and improving, Making effective decisions
- Leading and communicating, Collaborating and partnering, Building capability for all
- Achieving commercial outcomes, Delivering value for money, Managing a quality service, Delivering at pace
Expected Timeline:
Advert close: 23:55hrs on the 12th November 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.
Shortlist: w/c 13th November 2023
Interviews: TBC
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&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.
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 : Chloe Britten-Austin
- Email : UKHSA.recruitment@reed.com
Recruitment team
- Email : UKHSA.recruitment@reed.com
