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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).

Dundee is a coastal city on the Firth of Tay estuary in eastern Scotland. Its regenerated waterfront has 2 nautical museums: RRS Discovery, Captain Scott’s Antarctic expedition ship, and 19th-century warship, HM Frigate Unicorn. North of the water, Verdant Works is a museum celebrating the city’s jute-manufacturing heritage. The McManus: Dundee’s Art Gallery & Museum displays art and archaeological finds.

In 2014, Dundee was recognised by the United Nations as the UK's first UNESCO City of Design for its diverse contributions to fields including medical research, comics and video games.

A unique feature of Dundee is that its two professional football clubs, Dundee F.C and Dundee United F.C, have stadiums all but adjacent to each other.

Today, Dundee is promoted as "One City, Many Discoveries" in honor of Dundee's history of scientific activities and of the RRS Discovery, Robert Falcon Scott's Antarctic exploration vessel, which was built in Dundee and is now berthed at Discovery Point. Biomedical and technological industries have arrived since the 1980s, and the city now accounts for 10% of the United Kingdom's digital entertainment industry, including mobile app development and gaming.

​Dundee is a great place to further your career in life sciences. If you are a looking for pharmaceutical jobs in Dundee, scientific careers in Dundee or want to discuss cell therapy, gene therapy, ATMP, medical device, technology, biotech or pharmaceutical job opportunities in Dundee, give our Next Phase team a call. The Scottish 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 Scotland, 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 Scottish area.