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
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).
South East England
South East England is one of the nine official regions of England. It consists of Berkshire, Buckinghamshire, East Sussex, Hampshire, the Isle of Wight, Kent, Oxfordshire, Surrey and West Sussex. Greater London is usually considered as a separate region, although it too is obviously located in the South East, bordering Kent, West Sussex, Surrey and East Sussex.
Major towns and cities in the South East of the UK include Brighton and Hove, Canterbury, Chichester, Oxford, Portsmouth, Southampton, Winchester, Crawley, Reading, Milton Keynes, Horsham, Farnham and Worthing. The South East of the UK is an economic hub and is second only to London in terms of its economy thanks in part to the location of Gatwick Airport in West Sussex and numerous Channel ports on the Kent coast.
Many global companies have their UK Headquarters in the South East of the UK, including a concentration of technology companies along the “M4 corridor” and numerous technology, clinical research, pharmaceutical, biotech, life science and engineering companies are located in the various counties comprising the South East of the UK.
The 'golden triangle' is the world-leading life sciences cluster of London, Oxford, Cambridge and England's greater south east.
This region is a hotbed of innovation, home to:
Four of the world's top 10 universities
Five our of seven of the UK's academic health science centres
Leading medical research institutes including hte Wellcome Trust, the Medical Research Council, Cancer Research UK, and the national Cell Therapy Catapult, focusing on stem cell research and industrialisation.
The golden triangle is being boosted further by a wave of significant new investment, including:
The Francis Crick Institute - bringing together 1,500 scientist under one roof
Imperial West - co0locating researchers and businesses on 25 acres.
UCL East - a cross-discipline enterprise and innovation centre focused on health and biological technologies on the site of Queen Elizabeth Olympic Park.
The Institute of Cancer Research - creating the world's second largest cancer research campus in south London.
AstraZeneca's Global R&D Centre - bringing together 2,000 employees in Cambridge.
South-East England is a great place to further your career in life sciences. If you are a looking for pharmaceutical jobs in the South East, scientific careers in the South East or want to discuss cell therapy, gene therapy, ATMP, medical device, technology, biotech or pharmaceutical job opportunities inthe South East, give our Next Phase team a call. The London 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 London, 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 area.