How to become a QP in Ireland: the degree, the experience and the HPRA route

What a Qualified Person does

A Qualified Person (QP) certifies that each batch of a medicine was made and checked according to the law and its marketing authorisation before it is released for sale or export. Without that signature, a batch cannot leave the site for the market.

The role comes from Directive 2001/83/EC. Article 48 says every holder of a manufacturing authorisation must have "permanently and continuously at his disposal the services of at least one qualified person". Article 49 sets the education and experience, Article 50 protected people already doing the job when the rules began, and Article 51 sets the duties: the QP must certify "in a register or equivalent document" that each production batch complies, and that register must be kept for at least five years.

EU GMP Annex 16, in operation since 15 April 2016, explains how certification works in practice. A QP may delegate checks to trained staff but must personally ensure that certification is permitted under the licence and is recorded. Annex 16 also says QPs "should be able to prove their continuous training" on product types, processes and GMP changes.

How to become a QP in Ireland: the requirements

You need two things: an education that meets Article 49, and at least two years of practical experience at a licensed manufacturer. The HPRA guide to attaining QP status (version 6, August 2026) sets out four routes in Ireland.

Source: HPRA Guide to Attainment of Qualified Person Status in Ireland, AUT-G0080-6, 14 August 2026; Directive 2001/83/EC.

Experience that does not count

The HPRA lists exceptions that catch people out. Time at a site that holds only an active substance registration, without an MIA, does not count. Nor does time at a site before its MIA was issued. Experience at a UK site counts only up to 31 January 2020, with one exception: Northern Ireland sites still count after that date. If you meet the education rule with two separate courses, you cannot add their lengths together to cut the two years.

Recognised QP courses in Ireland in 2026

Appendix 1 of the HPRA guide lists three Irish courses whose taught modules meet the educational requirements. The HPRA warns that "there are a number of courses with similar titles and not all are accepted", so check the exact course title before you register.

• Trinity College Dublin, Pharmaceutical Manufacturing Technology (MSc/P.Grad.Dip). A two-year online course running January to December. The next intake is January 2027 and the closing date is 31 October 2026. The MSc adds a QP professional dissertation worth 30 ECTS. See our Trinity College Dublin course listings.
• Atlantic Technological University Sligo, MSc in Industrial Pharmaceutical Science. Two years part-time, 90 credits, delivered online with a mandatory on-campus workshop in Sligo each semester. The fee is listed at €16,200 in total for EU students, and QP candidates need two years' practical industrial experience to enter.
• University College Cork, MSc in Pharmaceutical Technology and Quality Systems. Two years part-time, blended online learning with block attendance in Cork, €9,900 a year. Applicants should hold at least a second-class honours level 8 degree and be working in the sector. See our UCC course page.

Fees and dates were read on the universities' own pages in October 2026 and change each year. Our course finder lists other Irish life science courses, but only these three are on the HPRA list.

How the HPRA names you as a QP

Passing the course does not make you a QP. The HPRA guide says you become eligible to be a QP candidate, and your employer must apply for a variation to its manufacturing authorisation to add your name.

The application includes your qualifications and a summary of the QP training you completed at that site, written as a training programme for the role rather than a printout of standard operating procedures. The HPRA reviews your experience and training, and if it approves, your name and qualifications appear on the MIA. The HPRA says standard MIA variations take 30 to 90 days, depending on whether it asks for more information or needs an inspection.

How long it takes to qualify

Expect at least two years after your degree, and often four or more. The figures below come from the rules and the course pages above; there is no official average.

1. Degree. Article 49 asks for at least four years of university study, or a level 8 degree plus a recognised course.
2. Experience. At least two years at an EEA site with an MIA, which you can build while working in QA or QC.
3. Course. Each of the three Irish courses takes two years part-time. ATU asks QP candidates for two years' industrial experience before they start, so on that route the course follows the experience.
4. Nomination. Site training, then an MIA variation that the HPRA says takes 30 to 90 days.

All three courses are part-time and built for people already working in the industry. The experience the law asks for is in quality assurance, analysis and testing, so QA and QC jobs are the natural way in: our guide to CAPA and root cause analysis covers work a QP reviews every day.

Which Irish sites need a QP

Every site with a manufacturing authorisation must have at least one QP named on it. According to the EU register EudraGMDP, 258 Irish sites held a GMP certificate (426 certificates in all) when we read it on 20 September 2026.

Our Ireland pharma map shows 331 operating manufacturing sites on the island of Ireland, including about 72 pharma or API sites, 20 biologics sites and 13 animal health sites. The QP rule comes from medicines law, so it applies to sites that make, import or certify human, veterinary or investigational medicines. It does not apply to the roughly 165 sites that make only medical devices, and API-only sites registered without an MIA do not count towards QP experience. The largest clusters are in Galway (50 sites), Cork (44) and Dublin (44).

To see who is recruiting, use who's hiring in Irish life sciences. For pay, read our analysis of QP salaries in Irish biopharma in 2026 and the Irish salary guide.