Pharmaceutical Quality Assessor

Job summary

About the VMD

The VMD is the regulatory and policy lead responsible for issues concerning the authorisation, use, and manufacture of veterinary medicines in the UK.

Our aim is to protect public health, animal health, and the environment, and promote animal welfare by assuring the safety, quality and effectiveness of veterinary medicines.

Find out more at: About us - Veterinary Medicines Directorate - GOV.UK

About the Job

This exciting and interesting job puts you at the heart of authorising veterinary medicines for the UK market and plays a major role in assuring the quality and hence the safety and efficacy of these medicines. You will be a member of the Quality team, one of three specialist teams within the Pharmaceuticals Section, which is in turn part of the Authorisations Division.

The main role of the Quality team is to assess quality data submitted by companies in support of their application for marketing authorisations for veterinary medicines, and applications to vary these authorisations. The Quality team also has a significant role in the delivery of the VMD's regulatory science strategy, development of regulatory and scientific guidelines, assessment of product defects, and supporting delivery of the VMD's international activities, including training other veterinary medicines regulators.

Job description

You will be responsible for:

• the assessment of chemistry and pharmaceutical data for applications for:

- new marketing authorisations for pharmaceutical veterinary medicines.
- variations to existing marketing authorisations.
- quality aspects of animal test certificates (ATCs) to conduct clinical field trials.

• collaborating with members of the Authorisations Division to achieve the Division’s overall objectives.

Your main duties will be to:

• scientifically assess pharmaceutical data submitted by companies in support of their applications in line with legislative timelines and relevant guidance documents. These applications may encompass new marketing authorisations, ATCs, as well as variations to current marketing authorisations.
• undertake a detailed evaluation of pharmaceutical data and, in liaison with other assessors, formulate a recommendation to accept or refuse the application, based on the benefits and risks you identify during the assessment.
• produce a written report that forms the quality section of the overall VMD assessment report for the application.
• peer review assessment reports prepared by other quality assessors.
• communicate your assessments clearly to internal decision-making groups - to enable them to decide whether the data satisfy regulatory requirements and to decide on a course of action.
• advise applicants on technical aspects of potential and ongoing applications.
• deal with enquiries and represent the quality team at meetings with internal and external stakeholders.
• maintain and develop a thorough working knowledge of own specialism.
• maintain awareness of current developments, legislation and guidance affecting pharmaceutical veterinary medicines within National and International context.
• contribute to the production of relevant training materials in order to pass on knowledge to other members of the VMD, as well as external clients.
• comply with ISO 9001 (quality management) and ISO 27001 (information security) standards, and GDPR and Information Management requirements.
• act corporately – meeting, role-modelling, embedding, and championing the corporate objectives set by the VMD.

Though these are not part of your main duties, we may also ask you to:

• manage and develop junior assessors in the team.
• contribute to development and revision of industry guidelines.
• contribute to the delivery of the VMD International Strategy (which may involve foreign travel)
• contribute to the VMD Regulatory Science Strategy
• contribute to the VMD R&D programme
• contribute to the establishment of enhanced external regulatory and scientific networks

Person specification

We’re looking for someone that:

• has the ability to critically analyse scientific information from a range of sources and make sound judgements for medicines.
• has excellent written and verbal communication skills.
• has experience within the pharmaceutical industry or academia in at least one of the following: regulatory affairs, research and development, manufacture, or quality control of medicinal products.
• has knowledge of relevant legislation and procedures applicable to the licensing of medicinal products.
• is proficient in the use of Microsoft Office 365, particularly Word, Excel, Outlook and Teams, be able to use or learn to use Sharepoint, and be prepared to learn to use VMD bespoke databases.

Qualifications

Applicants must have a degree or equivalent in Chemistry, Pharmacy, Pharmaceutical science, or another relevant subject.

Behaviours

We'll assess you against these behaviours during the selection process:

• Making Effective Decisions
• Communicating and Influencing
• Developing Self and Others

We only ask for evidence of these behaviours on your application form:

• Making Effective Decisions
• Communicating and Influencing

Technical skills

We'll assess you against these technical skills during the selection process:

• Scientific assessment of pharmaceutical quality data

Benefits

Alongside your salary of £47,557, Veterinary Medicines Directorate contributes £13,777 towards you being a member of the Civil Service Defined Benefit Pension scheme. Find out what benefits a Civil Service Pension provides (opens in a new window).

• Learning and development tailored to your role
• An environment with flexible working options
• A culture encouraging inclusion and diversity
• A Civil Service pension is one of the best workplace pension schemes in the UK public sector, with an average employer contribution of 28.97%
• Free onsite parking
• Free eyesight test
• Onsite gym
• Access to a prayer room

Awork-life balance is key for us all. We offer flexible working as well as health, well-being and discount schemes. The annual leave package starts at 25 days per year and increases to 30 days over five years. We offer generous maternity, paternity, shared, and adoption leave.

This gives you a flavour of what’s available, but there is so much more we could mention – see Civil Service Employee Benefits , Civil Service Careers for further information

Things you need to know

Artificial intelligence

Artificial intelligence can be a useful tool to support your application, however, all examples and statements provided must be truthful, factually accurate and taken directly from your own experience. Where plagiarism has been identified (presenting the ideas and experiences of others, or generated by artificial intelligence, as your own) applications may be withdrawn and internal candidates may be subject to disciplinary action. Please see our