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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
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).
Stevenage is a town in Hertfordshire approximately 35 miles north of London. Although there is evidence of a Roman settlement, Stevenage grew very slowly over the centuries. However, in 1946 Stevenage was designated Britain’s first “New Town” which meant six neighbourhoods being developed to help resolve the UK’s post-war accommodation problems. Opened by the H.M. the Queen in 1959, Stevenage's pedestrianised town centre was the first traffic free shopping zone in Britain. From a business point of view, Stevenage has become a centre for Life Sciences thanks to the Stevenage Bioscience Catalyst which aims is to support the next generation of pharma and biotech companies by offering access to equipment and facilities and in so doing placing the UK bioscience sector at the forefront of worldwide biomedical innovation. More recently Stevenage has become famous for the annual rock and pop festival held at Knebworth.
Famous people born in Stevenage: Lewis Hamilton, F1 motor racing world champion and Ian Poulter, professional golfer