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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).
Swindon is a town in Wiltshire, in the South West region of England. It is located approximately 35 miles from both Bristol and Reading and 78 miles from London. Other major towns within reasonable distance include Oxford, Cheltenham and Salisbury. Swindon is on the main railway line from Bristol to London Paddington and, with an average journey time of only 1 hour to London, it is a major commuter town. Road connections are also good, thanks to the proximity of the M4 motorway. Although many residents commute to London, Bristol and other cities, a substantial number of major employers are located in Swindon including engineering firms such as Honda, BMW/Mini and Halcrow as well as W H Smith's HQ and distribution centre and pharmaceutical companies including Patheon, Catalent Pharma Solutions and Vygon (UK) Ltd. Swindon also has the head office of the National Trust, the UK Space Agency and national Research Councils including the Biotechnology and Biological Sciences Research Council.
Swindon has two major museums; the STEAM Museum which provides a detailed history of the Great Western Railway and the Museum of Computing, it is also home to the Bodleian Library's book depository, which contains 153 miles of bookshelves
Famous people from Swindon: Billie Piper; actress and Melinda Messenger; glamour model and TV presenter