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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).

Sunderland

Sunderland is a city in Tyne and Wear in the North East region of England.  Major towns and cities within easy reach of Sunderland include Newcastle upon Tyne which is ten miles away, Durham, 12 miles away, Manchester and Edinburgh, both of which are approximately 100 miles away.  Sunderland is a coastal city and port at the mouth of the River Wear and this location made it an ideal centre for shipbuilding.  Shipbuilding and coalmining were the major employers in Sunderland until after WW2 when increased competition from overseas resulted in the last shipyard closing in 1988 and the last coal mine in 1994.  Following the decline of these industries in the late 20th century, Sunderland grew into a commercial centre for the automotive industry science & technology and the service sector.   The Nissan plant is the largest car manufacturing site in the UK and companies such as EE, Royal Mail and EDF have set up their contact centres in the area.

A major attraction in Sunderland is the National Glass Centre which depicts the history of glass production in the area from 7th century to the present day and also offers visitors the chance to have a go at blowing glass.

Famous people from Sunderland: Emeli Sandé, singer and Lauren Laverne, DJ and presenter