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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).

Manchester

Manchester is a world class city in north-west England with excellent transport links including an international airport, the Manchester Ship Canal and easy access to the national motorway network.  Manchester was initially settled by the Romans, growing slowly during the Middle Ages and then rapidly around the turn of the 19th century, thanks to the textile industry, making it the birthplace of the Industrial Revolution.  The city continues to be an industrial and commercial powerhouse.  Manchester’s current strengths include Life Sciences, Manufacturing and Creative/Digital media.  Several medical research institutes and Europe’s biggest cancer treatment are located in Manchester as are numerous innovative software development, augmented reality, digital health, e-commerce and gaming companies.

The biological, medical and health sciences have a long and proud history at the University and in the city of Manchester.

Manchester is a place of world-firsts in cancer research, including the first clinical use of Tamoxifen for breast cancer and the first single harvest blood stem-cell transplant.

The study of medicine at Manchester can trace its roots back to 1814, when Joseph Jordan opened a school of anatomy in the city. From 1824, numerous medical schools opened in the city which, in 1836, amalgamated to form the Manchester Royal School of Medicine and Surgery, employing well-known names such as John Dalton, Edward Lund and Rochard Hunt. It was also in 1824 that the study of pharmacy began at Manchester Medical School.

The study of life sciences at Manchester goes back to 1851, when Owens College was founded and William Crawford Williamson was appointed as professor of natural history with teaching responsibilities for botany, ohysiology, geology and zoology.

The Museum of Medicine and Health holds a significant collection of medical, nursing and pharmaceutical artefacts dating as far back as the 16th century.

Famous people from Manchester:-  Noel & Liam Gallagher (Oasis)  and Emmeline Pankhurst – Suffragette/Women’s rights activist