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About the job
Job summary
We have an exciting opportunity for a GMDP Inspector to join our Good Manufacturing & Distribution Practice (GMDP) Inspection Team within the Healthcare Quality and Access Portfolio.
This is a full-time opportunity, on a permanent basis. This is an exciting, varied and challenging role and no two days are the same.
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.
*Salary will be subject to candidates location.
National salary: £50,338 + £6000MPS per annum
London salary: £54,088 + £6000MPS per annum
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 portfolio 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 will enable 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.
Job description
Whats the role?
You will work as part of the Good Manufacturing & Distribution Practice (GMDP) Inspection team to reduce risk and assure the quality of medicinal products for patients, by performing inspections at a wide range of sites in the UK and 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. 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.
MHRA GMDP Inspectors have a range of backgrounds including Production, Quality Assurance, Quality Control and Validation. It is not a requirement to be eligible to act as a Qualified Person. You will be expected to demonstrate an in-depth knowledge of at least one final dosage form and be able to answer questions on associated facility design and applicable controls required to manufacture and test that dosage form. Demonstration of understanding of current EU GMP expectations applicable to that dosage form is also required. Alternatively, this could also apply to the manufacture and quality control of active pharmaceutical ingredients if that is your background.
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 will require you to travel overseas. 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 organise, conduct and report inspections at manufacturers, importers, wholesale dealers and hospital sites to ensure medicinal products are manufactured in compliance with EU GMP and national marketing authorisations.
- To work with other Regulatory Agencies and participate in inspections in accordance with the Compilation of Community procedures.
- To provide advice to stakeholders including participation in regulatory advice meetings and pathways, MHRA symposia and external meetings demonstrating good knowledge of national and international systems.
- To participate in joint/shadow inspections to expand knowledge base of inspectors e.g. GDP or other GXP inspections and WHO and EDQM inspections.
- To support the continued development of the GMP/GDP Inspectorate quality system by maintaining current knowledge and expertise in relevant scientific, professional and administrative matters.
Person specification
Who are we looking for?
Our successful candidate will:
- Have a degree in a relevant science, medical or engineering degree (e.g. pharmacy, chemistry, microbiology, pharmacology, biochemistry, biology, medicine, engineering).
- Have demonstrable experience of working in a Good Manufacturing Practice environment, which should include time in pharmaceutical manufacturing and/or quality assurance.
- Demonstrate the ability to write well-focused penetrating reports fully independently, to resolve critical issues and make effective presentations.
- Demonstrate the ability to work unsupervised for long periods of time, but also able to work within a team environment and demonstrate good planning and organisational skills to meet tight deadlines and manage multiple priorities.
- Be 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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Benefits
- Annual Leave: 25 days annual leave on entry, rising by one day for each completed year of service to a maximum of 30 days and pro-rata for part-time staff. PLUS 8 bank holidays
- Privilege Leave: 1 day
- Hours of Work: 37 hours (net) per week for full time staff in all geographical locations, including London and pro rata for part-time staff
- Occupational Sick Pay (OSP): One month full pay/one month half pay on entry, rising by one month for each completed year of service to a maximum of five months full pay/five months half pay
- Mobility: Mobility clause in contracts allowing staff to be mobile across the Civil Service
- Civil Service Pension Scheme. Please see the link for further information http://www.civilservicepensionscheme.org.uk/ For enquiries relating to the Civil Service Pension Schemes please contact MyCSP’s Pension Service Centre directly on 0300 123 6666
- Flexible working to ensure staff maintain a healthy work-life balance
- Interest free season ticket loan or bike loan
- Employee Assistance Services and access to the Civil Service Benevolent Fund
- Eligibility to join the Civil Service Motoring Association (CSMA)
- Variety of staff and Civil Service clubs
- On-going learning and development
Things you need to know
Selection process details
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.
· Interview, which can include questions based on the Behaviour, Experience, Technical and Strengths Success Profiles.
· Online tests
· Assessment Centre (further information will be supplied when you reach this stage)
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.
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 applicants 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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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).
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Job contact :
- Name : The Resourcing Team
- Email : Careers@mhra.gov.uk
Recruitment team
- Email : Careers@mhra.gov.uk
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