Qualified Person
A Qualified Person (QP) operates within the quality assurance function of a pharmaceutical company and has a crucially important role because he or she takes legal responsibility for certifying that batches of medicines are safe prior to release. This “batch release” refers to the release of medicines to be used in either clinical trials or for sale in the commercial market.
Qualified Persons must be nominated by certain regulatory bodies, one of which is the Royal Pharmaceutical Society, to certify that they are eligible for the role. In the UK and most of Europe, nominations for QP status are subsequently approved by the Medicines and Healthcare products Regulatory Agency (MHRA), which has the final say as to who can be named a Qualified Person within pharmaceutical manufacture. In order to be nominated as a QP, applicants must have an in depth understanding of the pharmaceutical industry, combined with extensive training that covers a number of different modules.
In a recent blog (bit.ly/2syLrq) Next Phase Recruitment Specialist Julie Nicholls explains that new EU Regulations coming into force soon will mean that medical device companies will now also need to appoint a Qualified Person. This will have significant implications for the UK market, where QPs are already in short supply. An experienced Qualified Person will often prefer to work on a consultancy basis, for the variety of work, significant daily pay rates, and ability to work with a number of different clients at the same time.
Skills and Experience required to become a QP
Typically a QP will need the following skills and experience:-
- Degree level education in a scientific discipline such as pharmacy, chemistry, biomedical science
- Nomination as a QP by a relevant regulatory body plus MHRA approval
- Detailed understanding of pharmaceutical law, quality management systems and the professional duties of a QP
- Substantial experience within the pharmaceutical industry
- Statistical and mathematical skills
- In-depth understanding of the manufacture and supply chain
- Leadership skills
Salary Level
Pay rates for QPs vary enormously depending on where they are based and their main areas of specialisation (e.g. IMP / commercial). A recently-registered Qualified Person may command a salary of £55k - £70k initially, but this can increase quickly to £75k - £95k once the QP has some post-qualification experience. Similarly, QP contract rates can vary a great deal. QP pay rates can be anything from £650 / day to £1,100 / day depending on the length and complexity of the contract, and this may also vary depending on what additional skills the QP can provide (such as a background in Pharmacy, for example).
East Sussex
East Sussex is a county in south East England to the south of London and bordered by the English Channel to the south. Major towns in East Sussex include Brighton and Hove, Lewes, Eastbourne, Rye and Hastings. Transport links in East Sussex are not particularly good as there are no motorways, but this doesn’t stop thousands of people visiting the beautiful coastline, rolling countryside and cosmopolitan Brighton, which means that the tourism industry is a major employer in this area. Other industries that are prominent in East Sussex include Pharmaceuticals, low carbon technologies, publishing, web & app design and Medical Communications. The otherwise quiet town of Lewes hosts the largest bonfire Night celebrations in the UK during which burning crosses and effigies are paraded through the town by 7 separate bonfire societies, watched by crowds of up to 80,000.
East Sussex has a School of Life Science which is a diverse, collaborative community with expertise in areas as varied as cancer biology, drug discovery, neurosciene and biodiversity. The University of Sussex is a leading research-intensive university near Brighton. We have both an international and local outlook, with staff and students from more than 100 countries and frequent engagement in community activities and services.
East Sussex has a small but growing life sciences and healthcare cluster of companies specialising in the research, development and manufacture of medical devices, biotechnology, poharmaceutical products and preparations and natural science and engineering research.
Daval International Ltd in Eastbourne focuses on the development and delivery of new treatments for neuro-degenerative, inflammatory and autoimmune diseases.
Companies also supply specialist services and instruments for life science labs and biotechnology industries. These include temperature monitoring systems (QCBug) and bespoke software solutions (Biomedical Computing Ltd).
Famous people born in East Sussex: Jo Brand, comedienne and Katie Price, “celebrity”
East Sussex is a great place to further your career in life sciences. If you are a looking for pharmaceutical jobs in East Sussex, scientific careers in East Sussex or want to discuss cell therapy, gene therapy, ATMP, medical device, technology, biotech or pharmaceutical job opportunities in East Sussex, give our Next Phase team a call. The East Sussex area is continuing to expand as a centre for jobs in science, process development, technology, software development, project management, informatics, quality, reg affairs and supply chain.
At Next Phase we help people find new jobs in life sciences across the UK, Europe and USA. This page lists some of the job opportunities in East Sussex, and if you give us a call we can also talk to you about other scientific jobs, pharmaceutical career opportunities and the latest updates in cell and gene therapy and ATMP development in the East Sussex area.
