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).
Ireland's Life Sciences sector has grown rapidly from modest beginnings in the 1960s to reach global significance. Collaborative clusters in Pharmaceutical, Biotechnology, Medical Devices and Diagnostics have been a key element behind this remarkable growth in a sector that accounts for 32% of GDP.
The sector continues to develop and evolve, more recently Ireland has expanded its global hub beyond commercialisation to include innovation, digitalisation and next generation technologies.
Ireland is the 3rd largest exporter of pharmaceuticals globally.
85+ Pharmaceutical companies operate in Ireland - and it has 9 of the world's top pharmaceutical companies.
50 FDA approved pharma and biopharma plants.
Dublin is the capital and largest city of Ireland. Situated on a bay on the East Coast, at the mouth of the River Liffey, it lies within the province of Leinster. It is bordered on the south by the Dublin Mountains, a part of the Wicklow Mountains range.
Dublin is the largest centre of education in Ireland, and is home to four universities and a number of other higher education institutions. It was the European Capital of Science in 2012.
The University of Dublin is the oldest University in Ireland, dating from the 16th century, and is located in the city centre. Its sole constituent college, Trinity College (TCD), was established by Royal Charter in 1592 under Elizabeth I. It was closed to Roman Catholics until 1793, and the Catholic hierarchy then banned Roman Catholics from attending until 1970. It is situated in the city centre, on College Green, and has over 18,000 students.
The National University of Ireland (NUI) has its seat in Dublin, which is also the location of the associated constituent university of University College Dublin (UCD), which has over 30,000 students. Founded in 1854, it is now the largest university in Ireland.
As of 2019, Dublin's principal, and Ireland's largest, institution for technological education and research, Dublin Institute of Technology (DIT), with origins in 1887, has merged with two majour suburban third level institutions, Institute of Technology, Tallaght and Institute of Technology, Blanchardstown, to form Technological University Dublin, Ireland's second largest university by student population. The new university offers a wide range of courses in areas including engineering, architecture, scieces, health, journalism, digital media, hospitality, business, art and design, music and the humanities programmes, and has three long-term campuses, at Grangegorman, Tallaght and Blanchardstown.
Dublin City University (DCU), formerly the National Institute for Higher Education (NIHE) Dublin, offers courses in business, engineering, science, communication courses, languages and primary education. It has around 16,000 students.
The Royal College of Surgeons in Ireland (RCSI) conducts a medical school which is both a university and a recognised college, there are also large medical schools within UCD and Trinity College. The National College of Ireland is also based in Dublin, as well as the Economic and Social Research Institute, a social science research institute.
Ireland is a great place to further your career in life sciences. If you are a looking for pharmaceutical jobs in Dublin, scientific careers in Dublin or want to discuss cell therapy, gene therapy, ATMP, medical device, technology, biotech or pharmaceutical job opportunities in Dublin, give our Next Phase team a call. The Irish 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 Dublin, 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 Dublin area.