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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).
Maidenhead is a large town in the county of Berkshire in the South-East region of England approximately 30 miles from London, 13 from Reading and 32 from Oxford. Other major towns within easy reach of Maidenhead include Slough, Marlow, Henley on Thames and Windsor. Maidenhead enjoys excellent transport connections, being located on the A4 and M4 and having regular trains services into London which means that many residents commute into London, Slough, Reading and other towns.
The three main industries in Maidenhead and surrounding areas are pharmaceuticals & life science, visitor economy and digital technologies. Pharmaceutical and Life Science companies in the Maidenhead area include Abbvie, GSK and Johnson & Johnson, Abbott Laboratories, Biogen Idec, Covance, Inventiv Health, Sanofi Pasteur and Seqirus. Maidenhead lies on the “Silicon Corridor” which is home to numerous digital and other technology companies Telecommunications, Cyber Security, Data Centres and Cloud Computing, Big Data companies include Adobe, Hitachi, 3, LexMark and Fujitsu. The Royal Borough of Windsor and Maidenhead is home to many famous attractions including Windsor Castle, Legoland, Royal Ascot and Eton College. It also boasts many high-quality hotels and four restaurants with 3 Michelin stars. As a result, the visitor economy is a major employer in the area.
Famous people from Maidenhead: Geraldine James, actress and Hugh Lofting, author and creator of Dr Dolittle.