We have an opportunity for a Laboratories Inspector to join our Good Laboratory Practice and Laboratories Team within the Standards & Compliance function of the Healthcare Quality & Access Group. This is an opportunity to join a multi disciplinary team who conduct GLP, GCP and GMP QC inspections of Laboratories and research organisations.
This is a full time opportunity, on a permanent basis. This is an interesting, varied and challenging role.
The role will be home based, with travel to our Canary Wharf, London or South Mimms, Hertfordshire offices. Please be aware that this role can only be worked in the UK and not overseas.
Who are we?
The Medicines and Healthcare products Regulatory Agency enhances and improve the health of millions of people every day through the effective regulation of medicines and medical devices, underpinned by science and research.
The objective of the Healthcare Quality and Access group is to drive quality and critically appraise benefits and risks to inform robust decisions on healthcare access including accelerated access pathways.
The Standards & Compliance function enables innovation and healthcare access across the global product lifecycle by risk proportionate standards development and compliance through the British Pharmacopoeia and MHRA Laboratory, the Compliance Teams, the Inspection Action Group and Devices Audit and Compliance.
The group also contains the United Kingdom Good Laboratory Practice Monitoring Authority, who are responsible for the compliance monitoring of facilities performing non-clinical safety testing of test items contained in pharmaceutical products, pesticide products, cosmetic products, veterinary drugs as well as food additives, feed additives, and industrial chemicals.
What’s the role?
You will work as part of the our Good Laboratory Practice (GLP) and Laboratories Inspection team to reduce risk and improve the quality of medicinal products for patients, also public and environmental safety by performing inspections at a wide range of sites in the UK and possibly overseas, to assess the compliance of organisations with their legal obligations.
You will be required to perform inspections as part of a team where you may be the lead inspector and also on your own. Your experience, knowledge and judgement will be called upon extensively in this role.
The work of an inspector is not a 9 to 5 job and involves overnight stays and at times requires early starts and late finishes. This is balanced by the ability to set your own schedule and plan your travel in a way that suits you. After a training period, inspectors are allocated a programme of inspections and can usually decide for themselves on the exact timings, how they will get there and where they will stay if an overnight stay is required (subject to the MHRA travel policy). Few jobs offer this degree of flexibility and autonomy.
You may also be involved in other activities such as presenting at conferences and training events, dealing with international bodies and other regulatory authorities and helping to drive forward regulatory processes within the UK and further afield with the ultimate aim of protecting public health.
Excellent inter-personal skills are required as Inspectors provide a key contact between the agency and our stakeholders.
Laboratories Inspectors currently have a range of backgrounds including Quality Assurance, Quality Management, consultancy and laboratory operations across a variety of the GxPs e.g. GLP, GMP and GCP.
Experience of or an ability to understand the applicable regulations in the area of experience is also required. This is the starting point for inspector training, and we will build on this knowledge during your initial accreditation period. You will be able to further develop your breadth of knowledge and skills as part of ongoing training and development.
It is a condition of employment that Inspectors are willing and able to travel on company business. We may be required to travel overseas (depending on specialism). You will also be required to visit our other sites (Canary Wharf, London or South Mimms, Hertfordshire) periodically to attend meetings and training events.
Key responsibilities:
- To perform a range of inspections which can include:
- Good Clinical Practice inspections of laboratories performing analysis of clinical trial samples
- Good Laboratory Practice inspections of facilities conducting non-clinical safety studies
- Good Clinical Practice inspections of bioequivalence studies,
- Inspection of laboratories performing Good Manufacturing Practice quality control testing.
- To work with other Regulatory Agencies and participate in joint inspections in accordance as required.
- To work closely across inspection teams, agency departments and external regulators to ensure inspection activities are communicated effectively.
- To support the continued development of the Inspectorate quality system by maintaining current knowledge and expertise in relevant scientific, professional and administrative matters.
Our successful candidate will:
- A degree in a relevant science, medical or engineering degree (e.g. pharmacy, chemistry, microbiology, pharmacology, biochemistry, biology, medicine, engineering)
- Significant relevant experience in a relevant discipline
- Ability to work unsupervised for long periods of time, but also able to work within a team environment demonstrating good planning and organisational skills to meet tight deadlines and manage multiple priorities
- Proven ability to analyse and identify issues, make sound decisions, take appropriate actions tactfully and effectively, influence key stakeholders and take responsibility for results.
- IT literate including skills in Microsoft Office
If you would like to find out more about this fantastic opportunity, please read our Job Description and Person Specification!
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The selection process:
We use the Civil Service Success Profiles to assess our candidates, find out more here.
- Online application form, including questions based on the Behaviour, Experience and Technical Success Profiles. Please ensure all application questions are completed in full; your application may not be considered if any responses are left blank. Our applications are CV blind, and our Hiring Managers will not be able to access your CV when reviewing your application.
- Video or telephone interview, which can include questions based on the Behaviour, Experience, Technical and Strengths Success Profiles. In person interview may also be required.
- Online tests
- Assessment centre
Applicants are assessed on whether they meet any mandatory requirements as well as the necessary skills and experience for the role.
If you require any disability related adjustments at any point during the process, please contact careers@mhra.gov.uk as soon as possible.
Closing date: 15/05/2023
If you need assistance applying for this role or have any other questions, please contact careers@mhra.gov.uk
Candidates will be subject to UK immigration requirements as well as Civil Service nationality rules. Further information on whether you are able to apply is available here.
Successful candidates must pass a disclosure and barring security check as well as animal rights and pro-life activism checks. People working with government assets must complete basic personnel security standard checks.
Applicants who are successful at interview will be, as part of pre-employment screening subject to a check on the Internal Fraud Database (IFD). This check will provide information about employees who have been dismissed for fraud or dishonesty offences. This check also applies to employees who resign or otherwise leave before being dismissed for fraud or dishonesty had their employment continued. Any applicant’s details held on the IFD will be refused employment. A candidate is not eligible to apply for a role within the Civil Service if the application is made within a 5 year period following a dismissal for carrying out internal fraud against government.
Any move to the MHRA 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 here.
Successful candidates may be subject to annual Occupational Health reviews dependent on role requirements. If you have any queries, please contact careers@mhra.gov.uk.
In accordance with the Civil Service Commissioners’ Recruitment Principles our recruitment and selection processes are underpinned by the requirement of selection for appointment on the basis of merit by a fair and open competition. If you feel your application has not been treated in accordance with the Recruitment Principles and you wish to make a complaint, you should firstly contact Mira Mepa, Head of Recruitment and Operations, Mira.Mepa@mhra.gov.uk.
If you are not satisfied with the response you receive, you can contact the Civil Service Commission at: civilservicecommission.independent.gov.uk
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