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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).

Essex

Essex is a county located to the north-east of London in the East of England region.  Major towns and cities in Essex include Colchester, Chelmsford, Basildon, Harlow, Romford and Southend.  Much of Essex is agricultural land, but the south has a concentration of industries including electronics, life science, pharmaceuticals, engineering and services.  Thanks to its close proximity to London and Cambridge Essex has been able to develop as a high-tech cluster for research and development in industry sectors including Life Sciences, healthcare and renewable energies.   As home to both Stansted and Southend airports as well the ports of Tilbury, Harwich and the UK’s largest container terminal in Thurrock, the Logistics industry is also a major employer in Essex.

Essex has 350 miles of coastline with windswept saltmarshes and tidal inlets which are rich in wildlife in contrast to traditional seaside resorts with piers at Southend and Clacton.  Other popular visitor attractions in Essex include Colchester with its Roman remains, castle and zoo, numerous National Trust houses and gardens and Lakeside shopping centre.

Famous people born in Essex: Jamie Oliver, TV chef and Russel Brand, comedian