Bernard Naughton
Director of the MSc in Pharmaceutical Manufacturing Technology (online) School of Pharmacy and Pharmaceutical Sciences, Trinity College Dublin
Science graduates looking to the future for a senior position with further responsibility should consider becoming a Qualified Person in a pharma company. It’s a springboard to a rewarding and high-flying industry career.
When considering a career in the pharma industry, graduates may not automatically think about becoming a Qualified Person (QP). However, they should, explains Bernard Naughton, Assistant Professor, School of Pharmacy and Pharmaceutical Sciences at Trinity College Dublin. Being a QP is an extremely responsible, well-respected and well-paid role.
Critical role of a Qualified Person in pharma
A QP is a highly skilled scientist responsible for signing off the final batches of medicines before they are released for sale. “It’s a very important quality assurance position,” says Professor Naughton.
“QPs must understand a medicinal product in detail and any issues that may arise in its manufacture. It’s a QP’s job to assess all the data they receive from other teams and make the decision as to whether a finished batch should be released or not.”
QPs must understand a medicinal
product in detail and any issues
that may arise in its manufacture.
Careers opportunities in Ireland and across the EU
Under EU legislation, every pharma manufacturer operating in EU member states must employ a Qualified Person. “Every pharmaceutical company has at least one QP, and most have several,” explains Professor Naughton. “As Ireland is the seventh largest net exporter of drugs in the world — and the largest in the EU — there are many QP opportunities within the Irish pharma sector and across the EU.” In the EU, QPs do not have to be qualified pharmacists. Science graduates who undertake additional educational and practical training can be eligible for the role.
Studying to become a Qualified Person
Typical QP candidates will have worked for three or more years in a quality assurance (QA) or quality control (QC) department in the industry before studying for another qualification. One such qualification is the MSc in Pharmaceutical Manufacturing Technology offered by Trinity College Dublin. It offers hybrid opportunities (including site visits to manufacturing plants) but can be completed entirely online and attracts students from across the world.
A QP’s personal qualities are also important. “They should be analytical, good at problem-solving and have high levels of honesty and integrity,” says Professor Naughton. “To move into more senior roles, they will need to be able to lead and innovate. Many graduates of our programme have gone on to take up roles as Heads of Quality within the industry, showing that becoming a QP is an important first step on a high-flying career path.”
10.5281/zenodo.10409156
