We currently have exciting opportunities for GMDP Inspectors to join our Good Manufacturing & Distribution Practice (GMDP) Inspection team within the Healthcare Quality and Access group.
These roles will be full-time, on a permanent basis and there are 6 available posts. These are exciting, varied and challenging roles and no two days are the same.
These roles will be home based, with travel to our Canary Wharf, London or South Mimms, Hertfordshire offices. Please be aware that these roles 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 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.
What’s 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.
- 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.
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.