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).
Basel is a city on the Rhine River in northwest Switzerland close to the borders with France and Germany. The official language of Basel is German although, with 35% of the inhabitants being foreign nationals, English is also widely spoken. The University of Basel, founded in 1460, is Switzerland's oldest university and it houses some of Erasmus’s works. Erasmus’s tomb is to be found in the city’s 12th century Romanesque-Gothic cathedral. There are almost 40 museums in Basel as well as many beautiful medieval buildings around the Marktplatz.
Basel is home to large pharmaceutical and chemical industries with companies such as Novartis, Syngenta, Ciba Specialty Chemicals, Hoffmann-La Roche, and Actelion being headquartered in the city. Like other Swiss cities, Basel is also a centre for banking and both the Bank for International Settlements and UBS are located in the city. The Basel Area is one of the most sought-after life sciences locations in the world, and is clearly Europe’s top life sciences hub. Roche and Novartis, two out of three global pharma market leaders have their global headquarters here.
Basel can also rightly claim the longest history in life sciences. From the beginnings with its industrial silk ribbon dye mills in the mid-century 1800s up to the biotech revolution, the region’s life sciences ecosystem has repeatedly evolved and reinvented itself in the course of the industry’s larger developments. This success story is still going strong and will continue.
The Basel Area is home to over 700 life sciences companies that are making a substantial contribution to a dynamic business environment. The life sciences industry is the growth engine of the Basel Area – homegrown and here to stay. The Basel Area is also a hotspot for promising startups, such as docdok.health AG, Versameb AG, Polyneuron Pharmaceuticals AG, T3 Pharmaceuticals AG and Cellestia Biotech AG.
The Basel Area is also a world champion in gross value. The $66 billion USD exports of pharma products per year are impressive.
Famous people from Basel include: Roger Federer, champion tennis player and Ursula Andress, actress.
Switzerland is a great place to further your career in life sciences. If you are a looking for pharmaceutical jobs in Basel, scientific careers in Basel or want to discuss cell therapy, gene therapy, ATMP, medical device, technology, biotech or pharmaceutical job opportunities in Basel, give our Next Phase team a call. The Swiss 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 Switzerland, 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 Basel area.