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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).

Lying on the river Tywi, Carmarthen is the county town of Carmarthenshire in Wales and is located approximately 30 miles from Swansea and 70 miles from Cardiff.  The town was founded by the Romans and 1000 years later Carmarthen Castle, built by the Normans, became their regional capital.  In the 19th century the development of the coal mining industry meant that growth moved away from Carmarthen to other areas in South Wales.  The main industries in Carmarthen today are agriculture, fishing, forestry and tourism.  The town is within easy reach of the Brecon Beacons National Park and the beautiful Pembrokeshire coast as well as many other visitor attractions including the Dylan Thomas Boathouse in Laugharne, Kidwelly Castle, the National Wool Museum and the Dolaucothi Gold Mines.

Famous people from Carmarthen:

Rhod Gilbert, Comedian and Philip Vaughan, inventor of the ball bearing.

Carmarthen is a great place to further your career in life sciences. If you are a looking for pharmaceutical jobs in Carmarthen, scientific careers in Carmarthen or want to discuss cell therapy, gene therapy, ATMP, medical device, technology, biotech or pharmaceutical job opportunities inCarmarthen, give our Next Phase team a call. The Welsh area is continuing to expand as a centre for jobs in science, process development, technology, software development, project management, informatics, quality, reg affairs and supply chain.

At Next Phase we help people find new jobs in life sciences across the UK, Europe and USA. This page lists some of the job opportunities in Carmarthen, and if you give us a call we can also talk to you about other scientific jobs, pharmaceutical career opportunities and the latest updates in cell and gene therapy and ATMP development in the Welsh area.