Good Manufacturing Practice Inspector

6 days ago


London, United Kingdom Medicines and Healthcare products Regulatory Agency Full time

We are currently looking for a **Good Manufacturing Practice Inspector** to join our **Standards & Compliance** Function** within the **Healthcare Quality and Access group**.***

This is a **full-time** opportunity, on a **permanent **basis. The role will is homebased but will require occasional travel to 10 South Colonnade, Canary Wharf London, E14 4PU/South Mimms, Hertfordshire. 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 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.

**What’s the role?**

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 postholder will be a part of the Good Manufacturing Practice (GMP) Compliance Team whose remit is to perform inspections at a wide range of sites in the UK and potentially overseas to assess the compliance of pharmaceutical manufacturing organisations with their legal obligations. The role also involves engaging with stakeholders across a variety of platforms to help improve industry compliance and contribute to safeguarding public health.

As a GMP Inspector, you will be part of a dynamic and supportive team. In your role, you will have autonomy in how to plan and structure your day-to-day work, including inspections.

Further information on the accreditation process will be provided during the various stages of recruitment.

**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 GMP and national marketing authorisations. This includes planning, conducting and reporting inspections and assessing the adequacy of responses from the inspected organisation.
- To provide advice and engage effectively with external stakeholders across a variety of platforms.
- 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 Compliance Team quality system by maintaining current knowledge and expertise in relevant scientific, professional and administrative matters.

**Who are we looking for?**
- A degree in a relevant science, medical or engineering degree (e.g. pharmacy, chemistry, microbiology, pharmacology, biochemistry, biology, medicine, engineering).
- 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.
- Excellent verbal and written communication skills. 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

**The selection process**:

- Numerical and verbal reasoning test, further information will be supplied when you reach this stage, if you are successful, you will then progress to the next stage.
- The interview, will include questions based on the Behaviour, Experience, Technical and Strengths Success Profiles
- Assessment Centre

This will consist of a variety of activities carried so we can get to know a little more about you and your experience. Activities at the assessment centre may include a technical interview, production of a written report, data analysis exercise and a presentation.

There will also be opportunities to discover more about the role, working for the MHRA directly from inspectors and to ask any questions you may have.

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 provided
- ensure you have read these thoroughly and allow sufficient time. You can view the competencies for this role in the job description.

**Use of AI in Job Applications**

Applicants must ensure that anything submitted is **factually accurate and truthful**. Plagiarism can include presenting the ideas and experience of others, or generated by artificial intelligence, as your own.

Closing date: 1st October 2024

Shortlisting date: from 2nd October 2024

Interview date: week commencing 21st October 2024

Assessment: week commencing 4th November 2024

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 h


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