Job Description

Details

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Reference number

430058
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Salary

55,233
A Civil Service Pension with an employer contribution of 28.97%
GBP
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Job grade

Grade 7###

Contract type

Permanent###

Business area

MHRA - Healthcare, Quality and Access Group###

Type of role

Other###

Working pattern

Full-time###

Number of jobs available

4

Contents

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Location About the job Benefits Things you need to know Apply and further information

Location

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Remote working (anywhere in the UK)

About the job

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Job summary

We are currently looking for an

Good Manufacturing Practice Inspector t

o join our

Standards & Compliance Function

within the

Healthcare Quality and Access portfolio group

.


This is a

full-time

opportunity, on a

permanent

basis. The role will is a homebased role 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.


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.

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Job description

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.

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Person specification

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.

Benefits

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Alongside your salary of 55,233, Medicines and Healthcare Products Regulatory Agency contributes 16,001 towards you being a member of the Civil Service Defined Benefit Pension scheme. Find out what benefits a Civil Service Pension provides.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 Service Civil Service Pension Scheme. Please see the link for further information http://www.civilservicepensionscheme.org.uk/ For enquiries relating to the Civil Service Pension Schemes please contact MyCSP's Pension Service Centre directly on 0300 123 6666 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

Things you need to know

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Selection process details

Our successful candidate will demonstrate thew following;

A degree in a relevant science, medical or engineering degree (e.g. 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 read our and Person Specification!

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

careers@mhra.gov.uk



Feedback will only be provided if you attend an interview or assessment.###

Security

Successful candidates must undergo a criminal record check.
People working with government assets must complete baseline personnel security standard (opens in new window) checks.###

Nationality requirements

This job is broadly open to the following groups:


UK nationals nationals of the Republic of Ireland nationals of Commonwealth countries who have the right to work in the UK nationals of the EU, Switzerland, Norway, Iceland or Liechtenstein and family members of those nationalities with settled or pre-settled status under the European Union Settlement Scheme (EUSS) nationals of the EU, Switzerland, Norway, Iceland or Liechtenstein and family members of those nationalities who have made a valid application for settled or pre-settled status under the European Union Settlement Scheme (EUSS) individuals with limited leave to remain or indefinite leave to remain who were eligible to apply for EUSS on or before 31 December 2020 Turkish nationals, and certain family members of Turkish nationals, who have accrued the right to work in the Civil Service
Further information on nationality requirements
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Working for the Civil Service

The Civil Service Code sets out the standards of behaviour expected of civil servants.



We recruit by merit on the basis of fair and open competition, as outlined in the Civil Service Commission's recruitment principles .
The Civil Service embraces diversity and promotes equal opportunities. As such, we run a Disability Confident Scheme (DCS) for candidates with disabilities who meet the minimum selection criteria.
The Civil Service also offers a Redeployment Interview Scheme to civil servants who are at risk of redundancy, and who meet the minimum requirements for the advertised vacancy.###

Diversity and Inclusion

The Civil Service is committed to attract, retain and invest in talent wherever it is found. To learn more please see the Civil Service People Plan and the Civil Service Diversity and Inclusion Strategy .

Apply and further information

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Once this job has closed, the job advert will no longer be available. You may want to save a copy for your records.###

Contact point for applicants

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Job contact :

Name : The Resourcing Team Email : careers@mhra.gov.uk
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Recruitment team

Email : Careers@mhra.gov.uk ###

Further information

In accordance with the Civil Service Commissioners' Recruitment Principles our recruitment and selection processes are underpinned by the requirement of selection for appointment on the basis of merit by a fair and open competition. If you feel your application has not been treated in accordance with the Recruitment Principles and you wish to make a complaint, you should contact the Resourcing Team at Careers@mhra.gov.uk, in the first instance. If you are not satisfied with the response you receive you can contact the Civil Service Commission at: civilservicecommission.independent.gov.uk - info@csc.gov.uk - Civil Service Commission Room G/8 1 Horse Guards Road London SW1A 2HQ