Regulatory Compliance Officer

Bristol, ENG, GB, United Kingdom

Job Description

Details


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Reference number




427947
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Salary




33,422 - 46,580
AfC Band 6: 38,682 - 40,823 - 46,580 per annum, pro rata. HEO (National): 31,997 - 39,076 per annum, pro rata
A Civil Service Pension with an employer contribution of 28.97%
GBP
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Job grade




Higher Executive Officer
HEO / AfC Band 6###

Contract type




Permanent###

Type of role




Science###

Working pattern




Flexible working, Full-time, Job share, Part-time###

Number of jobs available




1

Contents


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Location About the job Benefits Things you need to know Apply and further information

Location


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Bristol

About the job


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Job summary




We are seeking a Regulatory Compliance Officer (HEO or AfC Band 6)

Salary bands:



AfC Band 6:

38,682 - 40,823 - 46,580 per annum, pro rata

HEO (National):

33,422 - 39,076 per annum, pro rata

Candidates holding HCPC registration will be appointed on NHS Terms & Conditions at NHS AfC Band 6. Candidates without HCPC registration will be appointed on Civil Service Terms and Conditions at HEO grade.




The laboratory in Bristol is situated within the Severn Pathology suite of laboratories at North Bristol NHS Trust Southmead site. The laboratory receives in excess of 1 million specimens a year from a large number of clinical specialties across the Bristol and Bath hospital trusts which contribute to an interesting and varied workload.


The post-holder supports the Quality and IVD programme in Infection Sciences, Severn Pathology, working with the Quality Implementation and 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.

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Working for your organisation




We pride ourselves as being an employer of choice, where Everyone Matters promoting equality of opportunity to actively encourage applications from everyone, including groups currently underrepresented in our workforce.


UKHSA ethos is to be an inclusive organisation for all our staff and stakeholders. To create, nurture and sustain an inclusive culture, where differences drive innovative solutions to meet the needs of our workforce and wider communities. We do this through celebrating and protecting differences by removing barriers and promoting equity and equality of opportunity for all.

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Job description




The applicant must have a keen interest in quality management and be educated to degree level or equivalent in microbiology or a related pathology discipline.


The laboratory is accredited to ISO 15189:2022 and we actively encourage CPD activities.

In return we will provide a comprehensive induction programme and you will be appraised on a yearly basis with a view to developing knowledge and skills where appropriate.


In collaboration with the Infection Sciences Laboratories Bristol Quality Manager and team to become familiar with the area of work for which he/she is Regulatory Compliance Officer and be familiar with relevant statutory requirements, including awareness of regulatory acts, clinical governance, risk management, Caldicott and quality policies and procedure of UKHSA Bristol.

Regulatory Compliance



To ensure that Infection Sciences Laboratories - Bristol comply with IVD regulations, relevant ISO and other accreditation standards in collaboration with the IVD Programme Core Team, Quality team, and other staff. To take delegated regulatory and quality management tasks from the Quality Manager and deputy. Work with others to fulfill 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 organization of inspections by third party assessors, such as UKAS, HSE and WHO assessors and to progress issues arising from these inspections. Assist the laboratory Quality Team and Quality 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 the continuous improvement in service delivery and quality compliance within all areas of Infection Sciences Laboratories Bristol, using modern methods in ensuring the highest standards of quality, regulatory and process control. To collaborate with the Quality Team and APCU Team within UKHSA, attending requirement 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. To perform any other duties required by the line manager and deputise for the line manager.

Health & Safety



Collaborate with the Quality Manager to ensure that relevant UKHSA health and safety policies are implemented in collaboration with the safety team. To ensure that incidents and accidents are reported on a timely basis and that the UKHSA's statutory responsibilities for health, safety and welfare matters are fulfilled, e.g. Reporting of Injuries, Diseases and Dangerous Occurrences Regulations. Liaise closely with Laboratory Safety Officers in collaboration with the Regulatory Compliance Manager to ensure that health, safety and welfare is afforded priority over other issues and to demonstrate a commitment to health, safety and welfare regarding self, staff and visitors. Work in a safe manner, report all accidents and incidents, comply with safety policies and procedures and participate in the internal and external safety audits, as required. Co-operate on mattes of health and safety to enable the UKHSA to comply with its health and safety responsibilities. Liaise with the Laboratory Safety Officer and Quality Manager to help resolve safety and quality issues highlighted through quality related activities. To attend mandatory fire, manual handling training, etc.

Your attention is drawn to the Health and Safety at Work, etc. Act 1974 which requires you to take reasonable care of the health and safety of yourself and others which may be affected by your acts and omissions at work; and co-operate with the UKHSA on matters of health and safety.

Communication



To communicate effectively and accurately by oral and written means, and to ensure full and effective communication throughout the laboratory, making certain that all staff are included where appropriate To attend training meetings, tutorials, lectures and conferences, etc. To take responsibility for internal communications.

Information Technology



Apply computer databases, word processing and other specialized software packages to all aspects of maintaining and developing quality systems, in particular Q-Pulse quality management software to support the quality systems in UKHSA Bristol. Use databases and software packages.

Other



The above is only an outline of tasks, responsibilities and outcomes required of the role. You will carry out any other duties as may reasonably be required by the Quality Manager, Head of Technical Services, or Head of Business Operations. The job description and person specification may be reviewed on an ongoing basis in accordance with the changing needs of the organization. ###

Person specification



Essential role criteria:



Science degree (biological science, environmental science, biomedical science, statistics) or equivalent in microbiology or a related pathology discipline OR Health and Care Professions Council - State Registration Biomedical Scientist/Clinical Scientist Evidence of continuing professional development and willingness to continue the learning process through academic or practical experience Sound knowledge of common IT programmes, including Q-Pulse and excellent keyboard and IT skills 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 Experience of implementing projects Excellent verbal and written communication, data analysis and statistical skill Ability to work on own initiative and as part of the team Excellent interpersonal, negotiating, and organisational skills, self-motivated, analytical and adaptable An understanding of and commitment to equality of opportunity and good working relationships

Desirable role criteria:



Quality management qualification and knowledge of Regulatory compliance An understanding of microbiology and its application in clinical practice and public health

Benefits


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Alongside your salary of 33,422, UK Health Security Agency contributes 9,682 towards you being a member of the Civil Service Defined Benefit Pension scheme. Find out what benefits a Civil Service Pension provides.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 employer contribution of 28.97%

Things you need to know


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Selection process details




This vacancy will be assessed using a competency-based framework which will assess your qualifications, knowledge and experience and / or skills and abilities outlined in the essential criteria.

Stage 1: Application & Sift




You will be required to complete an application form. You will be assessed on the listed (12) essential criteria, and this will be in the form of a:

Application form ('Employer/ Activity history' section on the application) 1000 word supporting statement.

This should outline how your skills, experience, and knowledge, provide evidence of your suitability for the role, with reference to the essential criteria.


The Application form and supporting statement will be marked together.

Longlisting:




In the event of a large number of applications we will longlist into 3 piles of:

Meets all essential criteria Meets some essential criteria Meets no essential criteria

The following will be taken through to the next stage:

Meets all essential criteria

Shortlisting:




In the event of a large number of applications we will shortlist on the following:

Substantial laboratory experience working in an accredited medical laboratory

Desirable criteria may be used in the event of a large number of applications / large amount of successful candidates.


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


Please do not exceed 1000 words. We will not consider any words over and above this number.


Feedback will not be provided at this stage.


Please note you will not be able to upload your CV. You must complete the application form in as much detail as possible. Please do not email us your CV.

Stage 2: Interview (competency based)




You will be invited to a (single) face to face interview at the Bristol site. If face to face interviews are planned, in exceptional circumstances, we may be able to offer a remote interview.


Knowledge, experience, skills & abilities will be tested at interview.


Once this job has closed, the job advert will no longer be available. You may want to save a copy for your records.

Eligibility Criteria - External




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

Location




This role is being offered as office/lab based at our site in Bristol.


If based at one of our labs, you will be required to have a Counter Terrorism Check security vetting check as a minimum. For meaningful National Security Vetting checks to be carried out individuals need to have lived in the UK for a sufficient period of time. You should normally have been resident in the United Kingdom for the last 3 years as the role requires Counter Terrorism Check (CTC) clearance. In exceptional circumstances UK residency less than the outlined periods may not necessarily bar you from gaining national security vetting and applicants should contact the Vacancy Holder/Recruiting Manager listed in the advert for further advice.

Future location




UKHSA is investing in a new state-of-the-art National Biosecurity Centre in Harlow, Essex, which will eventually bring together teams currently based at Canary Wharf, Colindale and Porton Down. For more details, please see: Huge biosecurity centre investment to boost pandemic protection - GOV.UK.


The new facilities will start becoming operational in the mid-2030s, with full completion by 2038. Staff will move in phases as facilities become available. If you're appointed to a role currently based at Canary Wharf, Colindale or Porton Down, please note that we'll continue investing in these sites for the next decade. As we get closer to the transition, we'll provide full information about relocation support available to staff.

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 Counter-terrorist Check.


For meaningful National Security Vetting checks to be carried out individuals need to have lived in the UK for a sufficient period of time. You should normally have been resident in the United Kingdom for the last 3 years as the role requires Counter Terrorism Check (CTC). UK residency less than the outlined periods may not necessarily bar you from gaining national security vetting and applicants should contact the Vacancy Holder / Recruiting Manager listed in the advert for further advice.

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 consider 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 it could be time accrued over that period.

Artificial Intelligence (AI)




Artificial Intelligence can be a useful tool to support your application, however, all examples and statements provided must be truthful, factually accurate and taken directly from your own experience. Where plagiarism has been identified (presenting the ideas and experiences of others, or generated by artificial intelligence, as your own) applications may be withdrawn and internal candidates may be subject to disciplinary action. Please see our candidate guidance for more information on appropriate and inappropriate use.


Link below:


Artificial intelligence and recruitment , Civil Service Careers

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.

Careers website




Please visit our careers site for more information https://gov.uk/ukhsa/careers

NHS Pension




This role is offered under Agenda for Change (AFC) Terms and Conditions.

If you are already on AFC T&Cs or accept the role on a fixed-term contract, you will be enrolled in the NHS Pension Scheme or keep your current AFC Pension. If you take the role on a loan or temporary promotion, you will retain your existing substantive T&Cs. If the role is available under either AFC or Civil Service T&Cs depending on your registration, your pension scheme will align accordingly.


Feedback will only be provided if you attend an interview or assessment.###

Security




Successful candidates must undergo a criminal record check.
Successful candidates must meet the security requirements before they can be appointed. The level of security needed is counter-terrorist check .



See our vetting charter .
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) 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
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Working for the Civil Service




The Civil Service Code 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 .
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.###

Diversity and Inclusion




The Civil Service is committed to attract, retain and invest in talent wherever it is found. To learn more please see the Civil Service People Plan and the Civil Service Diversity and Inclusion Strategy .

Apply and further information


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Once this job has closed, the job advert will no longer be available. You may want to save a copy for your records.###

Contact point for applicants



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Job contact :



Name : Gurkamal Bhambra Email : gurkamal.bhambra@ukhsa.gov.uk
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Recruitment team



Email : recruitment@ukhsa.gov.uk ###

Further information




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: Complaints@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: https://civilservicecommission.independent.gov.uk

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Job Detail

  • Job Id
    JD3894577
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Part Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Bristol, ENG, GB, United Kingdom
  • Education
    Not mentioned