Glp / Laboratories Inspector
4 weeks ago
We have an opportunity for a **Laboratories Inspector** to join our **Good Laboratory Practice and Laboratories **Team within the **Standards & Compliance function** of the **Healthcare Quality & Access Group**. This is an opportunity to join a multi disciplinary team who conduct **GLP**, **GCP** and **GMP QC** inspections of Laboratories and research organisations.
This is a **full time** opportunity, on a **permanent** basis. This is an interesting, varied and challenging role.
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.
**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 group 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 enables 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.
The group also contains the United Kingdom Good Laboratory Practice Monitoring Authority, who are responsible for the compliance monitoring of facilities performing non-clinical safety testing of test items contained in pharmaceutical products, pesticide products, cosmetic products, veterinary drugs as well as food additives, feed additives, and industrial chemicals.
**What’s the role?**
You will work as part of the our **Good Laboratory Practice (GLP) and Laboratories **Inspection team to reduce risk and improve the quality of medicinal products for patients, also public and environmental safety by performing inspections at a wide range of sites in the UK and possibly 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.
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.
Laboratories Inspectors currently have a range of backgrounds including Quality Assurance, Quality Management, consultancy and laboratory operations across a variety of the GxPs e.g. GLP, GMP and GCP.
Experience of or an ability to understand the applicable regulations in the area of experience is also required. 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 may be required to travel overseas (depending on specialism). 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 perform a range of inspections which can include:
- Good Clinical Practice inspections of laboratories performing analysis of clinical trial samples
- Good Laboratory Practice inspections of facilities conducting non-clinical safety studies
- Good Clinical Practice inspections of bioequivalence studies,
- Inspection of laboratories performing Good Manufacturing Practice quality control testing.
- To work with other Regulatory Agencies and participate in joint inspections in accordance as required.
- 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 Inspectorate quality system by maintaining current knowledge and expertise in relevant scientific, professional and administrative matters.
- A degree in a relevant science, medical or engineering degree (e.g. pharmacy, chemistry, microbiology, pharmacology, biochemistry, biology, medicine, engineering)
- Significant relevant experience in a relevant discipline
- 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
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