MHRA: Quality Assessor â Biological Products - London
MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY
POSITION: Quality Assessor â" Biological Products  Â
DIVISION: Licensing
LOCATION: London, Victoria
REF NO: LD209
HOURS: 36 Hours per week (excluding lunch break)
CONTRACT TYPE: permanent
GRADE AND SALARY RANGE: SEO £37,175+ depending on experience. Potential for further progression through professional assessor career development structure.
The organisation:
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 Licensing Division is responsible for the quality, safety and efficacy evaluation of all new medicinal products to be authorised for the UK. The Licensing Division employs over 150 pharmaceutical, medical and toxicology assessors in its work, including a number of internationally recognised experts. The MHRA employs around 70 pharmacists in a wide range of assessment and management positions.
Purpose of Role:
Reporting to the Unit Manager in the Biologicals and Biotechnology Unit, a Quality Assessor is required to assess the quality aspects of both initial and variation applications for marketing authorisations for biological products and take decisions on their suitability for approval.
Key responsibilities:
This is a challenging role and you will need to call upon all of your scientific and professional training to evaluate all aspects of product quality in applications for new marketing authorisations and variations to introduce changes to approved marketing authorisations for biological products. You will prepare reports and recommendations for UK and European expert committees and you will be highly influential in bringing new medicines to the European market.
Assessment:
The above criteria will be used when assessing your suitability for the position. When completing your application form you need to address the essential criteria detailed in table above using specific competency based examples. Â
Please ensure to review the full job description and competencies in relation to this position prior to applying. Applicants will be expected to meet and address all the competencies in order to be shortlisted for the interview stage. You can apply for this position by creating a job profile on the Civil Service Jobs Portal here: https://jobsstatic.civilservice.gov.uk/csjobs.html
We are an equal opportunities employer and welcome applications from suitably qualified people regardless of age, gender, sexual orientation, marital status, race, religion, politics or disability.
All civil servants work within the boundaries of the Civil Service Code. The Code sets out the duties and responsibilities of all civil servants. Please click on the link for more information: http://www.civilservice.gov.uk/about/values/cscode/index.aspx
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Please note that if you do not receive a response to your application within 6 weeks after the closing date you have not been selected for interview. Due to the high volume of applications we receive we do not provide feedback to candidates at application stage.
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