Job summary

We are currently looking for aGood Manufacturing Practice Inspectorto join ourStandards & ComplianceFunctionwithin theHealthcare Quality and Access group.

This is afull-timeopportunity, on apermanentbasis. 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.��

�

Job description

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.

This post is aimed at candidates with substantial GMP knowledge and experience gained within either manufacturing or quality assurance of manufacture of dosage forms.

The recruitment process consists of an application form, interview and assessment centre aimed at evaluating your experience and knowledge of GMP as well as your technical abilities and behaviours which will help you succeed in this role.

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.

�

Person specification

A degree in a relevant science, medical or engineering degree ( pharmacy, chemistry, microbiology, pharmacology, biochemistry, biology, medicine, engineering). Extensive experience working in a Good Manufacturing Practice environment, in pharmaceutical manufacturing and/or quality assurance and application of quality principles to the delivery of regulated activities. 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 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��

�

Benefits

Alongside your salary of �52,603, Medicines and Healthcare Products Regulatory Agency contributes �15,239 towards you being a member of the Civil Service Defined Benefit Pension scheme. 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 ServiceCivil Service Pension Scheme.� Please see the link for further information For enquiries relating to the Civil Service Pension Schemes please contact MyCSP's Pension Service Centre directly on �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�