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Civil Service Pension with an average employer contribution of 27%
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About the job
Job summary
We are currently looking for a GDP Inspector to join our Compliance Team 2 within the Healthcare Quality & Access group.
This is a full-time opportunity, on a permanent. The role will be home based with occasional travel to or London, South Mimms, and York offices.
Who are we?
The Medicines and Healthcare products Regulatory Agency enhance 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. It will do this by bringing together a fusion of our capabilities across both medicines and medical devices to enable licensing and market access, as well as ensuring compliance with regulations and standards.
GDP Inspectors work as part of the GDP 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, to assess the compliance of organisations with their legal obligations.
Job description
Whats the role?
With an in-depth knowledge of GDP or other controlled distribution systems and a clear demonstrable understanding of quality systems including quality risk management principles and the auditing of quality systems, our ideal candidate will also have the ability to analyse information and data, identify pertinent issues and prioritise and communicate them. In addition, you will be a decision maker, take responsibility for your own workload and the achievement of results, be a strong communicator, highly organized and efficient.
Key responsibilities:
- Organise and conduct inspections at wholesaler dealer sites to ensure medicinal products are sourced, stored, and distributed in compliance with EU Good Distribution Practice (GDP) guidelines and other relevant legislation.
- Report on inspections and use inspection outputs to identify a risk rating for sites in accordance with the Agencys Risk Based Inspection programme.
- Network with staff across the Agency and as appropriate with colleagues from other regulatory bodies within the UK, wider EU and Internationally.
- To undertake travel within the UK and work unsupervised for long periods of time, but also to work within a team environment using good planning and organisational skills to meet tight deadlines and manage multiple priorities.
Person specification
Who are we looking for?
Our successful candidate will:
- Significant relevant experience (e.g. experience of working or auditing at a management/supervisory level in a Good Distribution Practice environment, in an associated regulatory role or in an environment related to the holding and/or distribution of temperature sensitive products).
- Clear understanding of GDP or other controlled distribution systems.
- Demonstrate in-depth knowledge of GDP or a controlled distribution system, including the legal framework relevant to that system, its practical application, and legislative requirements.
- IT literate including skills in Microsoft Office
- Proven ability to write well-focused penetrating reports fully independently, to resolve critical issues and make effective presentations.
If you would like to find out more about this fantastic opportunity, please read our Job Description and Person Specification!
Please note: The job description may not open in some internet browsers. Please use Chrome or Microsoft Edge. If you have any issue viewing the job description, please contact careers@mhra.gov.uk
Benefits
£10,107 towards you being a member of the Civil Service Defined Benefit Pension scheme.
Find out what benefits a Civil Service Pension provides.
- 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 a statement of suitability, attached as a PDF demonstrating how you meet the person specification (Experience and Technical criteria). 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. Please ensure not to include any personal identifying information on your supporting information.
- Test, (Verbal and Numerical Reasoning Test) further information and available dates will be supplied when you reach this stage.
- Assessment Centre, further information and available dates will be supplied when you reach this stage.
- Interview, which can include questions based on the Behaviour, Experience, Technical and Strengths Success Profiles.
Applicants are assessed on whether they meet any mandatory requirements as well as the necessary skills and experience for the role. Applications are scored based on the competency-based answers and statement of suitability provided- ensure you have read these thoroughly and allow sufficient time. You can view the competencies for this role in the job description.
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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Contact point for applicants
Job contact :
- Name : The Resourcing Team
- Email : Careers@mhra.gov.uk
Recruitment team
- Email : Careers@mhra.gov.uk
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