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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).
In addition to being the capital city of the United Kingdom, London (aka Greater London) is one of the nine official regions of England and consists of 32 boroughs plus the City of London. London is a global city with a population of 9 million and is the most densely populated region in European.
London is the world's leading financial centre for international business and as such the financial services industry in London, including banking, insurance, broking and fund management make the largest contribution to London's economy. Other major industries in the London region include real estate, legal, accountancy, creative industries such as fashion, design and art, media and TV, legal, construction, London tourism, pharmaceuticals, biotech and retail. In recent years many technology companies, especially those in FinTech, have set up in the area of East London known as the “Silicon Roundabout”, putting London on the map as a key area of growth.
London has a wealth of iconic and world famous London attractions such as Buckingham Palace, St Paul’s Cathedral, the Tower of London, Tower Bridge, beautiful parks, numerous world class museums, a vibrant London theatre land and global cuisine, the combination of which attracted over 19 million visitors to London in 2016. London tourism numbers have received a substantial boost thanks to the hugely successful Olympic Games held in London in 2012.
Famous people born in London: Idris Elba, actor and Adele, singer.