Quality Assessor-67,158 p.a. + benefits London, England
Job description
We are currently looking for a Quality Assessor to join our Innovative Medicines Team within the Healthcare Quality and Access group.
This is a full-time opportunity, on a permanent. The role will be based in 10 South Colonnade, Canary Wharf London, E14 4PU. Please be aware that this role can only be worked in the UK and not overseas. We are currently implementing a flexible, hybrid way of working, with a minimum of 4 days per month working on site to enable the collaboration and contact with partners and stakeholders needed to deliver MHRA business. Attendance on site is driven by business needs so depending on the nature of the role, this can flex up to 8 days a month, with the remainder of time worked either remotely or in the office. Some roles will need to be on site more regularly. Remote working is potentially available for some specific roles. Please discuss this with the recruiting manager before accepting an appointment.
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 Group is to drive quality and critically appraise benefits and risks to inform robust decisions on healthcare access including accelerated access pathways. It will do this by bringing together a fusion of our capabilities across both medicines and medical devices to enable licensing and market access, as well as ensuring compliance with regulations and standards.
What’s the role?
The post holder will be part of the Biological Products Team, reporting to one of the Heads of Teams. Quality Assessors assess the quality of both initial and variation marketing authorisation applications for biological medicinal products and take decisions on their suitability for approval. Examples of Biological products can include monoclonal antibodies, gene and cell therapy products, blood derived products, vaccines.
The role encompasses a broad range of activities from assessing an application for a new active substance, a line extension, or a biosimilar, to providing scientific advice to companies around quality/regulatory issues for the development of new drug products.
Key responsibilities:
- Carry out the assessment of data provided in initial and variation marketing authorisation applications for biological products, making appropriate recommendations and decisions in line with the protection of public health.
- Prepare and present objective risk-based assessments or other scientific papers to expert advisory bodies.
- Manage own workload, working in conjunction with managers, support staff and other assessors to meet agency deadlines.
- Contribute to assessment policy and practice and proactively identify where such contributions would be beneficial.
- Display a high level of attention to detail to ensure up to date accurate data and documents are held on internal databases.
- Develop good working relationships and communicate effectively with colleagues and other internal and external stakeholders.
Who are we looking for?
Our successful candidate will:
- Have up to date specialist knowledge in one or more relevant scientific areas or broader knowledge across the range of scientific activities in relation to the pharmaceutical development, manufacture and quality control of biological medicinal products.
- Have a working knowledge of relevant legislation and procedures applicable to the licensing of human medicinal products.
- Hold a degree in pharmacy, biology, biological sciences, medicine or a related field with relevant postgraduate experience or PhD equivalent.
- Be able to work flexibly, with the ability to adapt to changing priorities and take responsibility for achieving a successful outcome.
- Experience within the pharmaceutical industry, hospital pharmacy or academia (or equivalent) in at least one of the following areas: regulatory affairs, research and development, or manufacture or quality control of biological medicinal products.
If you would like to find out more about this fantastic opportunity, please read our Job Description and Person Specification!
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The selection process:
We use the Civil Service Success Profiles to assess our candidates, find out more here.
- Online application form, including questions based on the Behaviour, Experience and Technical Success Profiles. Please ensure all application questions are completed in full; your application may not be considered if any responses are left blank. Our applications are CV blind, and our Hiring Managers will not be able to access your CV when reviewing your application.
- Interview, which can include questions based on the Behaviour, Experience, Technical and Strengths Success Profiles.
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.
If you require any disability related adjustments at any point during the process, please contact [email protected] as soon as possible.
Closing date: 18/08/2023
Interview date: W.C. 04/09/2023
If you need assistance applying for this role or have any other questions, please contact [email protected]
Candidates will be subject to UK immigration requirements as well as Civil Service nationality rules. Further information on whether you are able to apply is available here.
Successful candidates must pass a disclosure and barring security check as well as animal rights and pro-life activism checks. People working with government assets must complete basic personnel security standard checks.
Applicants who are successful at interview will be, as part of pre-employment screening subject to a check on the Internal Fraud Database (IFD). This check will provide information about employees who have been dismissed for fraud or dishonesty offences. This check also applies to employees who resign or otherwise leave before being dismissed for fraud or dishonesty had their employment continued. Any applicant’s details held on the IFD will be refused employment. A candidate is not eligible to apply for a role within the Civil Service if the application is made within a 5 year period following a dismissal for carrying out internal fraud against government.
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 however be eligible for other government schemes, including Tax-Free Childcare. Determine your eligibility here.
Successful candidates may be subject to annual Occupational Health reviews dependent on role requirements. If you have any queries, please contact [email protected].
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 firstly contact Mira Mepa, Head of Recruitment and Operations, [email protected].
If you are not satisfied with the response you receive, you can contact the Civil Service Commission at: civilservicecommission.independent.gov.uk
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