Inspections, Enforcement and Standards – GMDP Inspector
We are currently looking for a dedicated individual to join our Inspections, Enforcement and Standards Division as a GMDP Inspector.
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 agency is made up of c.1300 staff working across two main centres and peripatetically across the UK and abroad.
The primary role of MHRA inspectors is to perform statutory inspections across the full life cycle of medicines, both within the UK and overseas. You will be required to perform inspections; sometimes as part of a team where you may be the lead inspector and sometimes 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.
The role of an inspector is exciting, varied and challenging and no two days are the same.
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 3 sites (London, Potters Bar and York) periodically to attend meetings and training events.
Working from an office
MHRA has offices in the following locations:
10 South Colonnade, Canary Wharf, E14 4PU
NIBSC, Blanche Lane, South Mimms, Potters Bar, EN6 3QG
Foss House, 1-2 Peasholme Green, York YO1 7PX
Working from Home
Inspectors are permitted to work from home when they are not inspecting or required to attend a meeting/event. This helps to redress the work- life balance impact of a role that requires regular travel away from home.