Pharmaceutical Quality Assurance & Regulation / Dearbhú Cáilíochta Cógaisíochta & Rialachán

Sept 2021 – Grangegorman Campus

Honours bachelor degree in science or related discipline at 2.2 grade or higher or equivalent qualification. Applicants for the part-time course should be employed in a relevant industrial sector. Selection of suitable candidates will be by interview.

Note: Due to the considerable competition for our postgraduate programmes satisfying the minimum entry requirement is not a guarantee of a place. Depending on the programme of study applications will be assessed based on their academic grades and may also take into account their work/life experience. Applicants will also be required to attend an interview for specific programmes.

Interviews will be virtual, applicants do not have to attend in person.

The MSc in Pharmaceutical QA and Regulation provides specific education at postgraduate level in ‘Quality Assurance’ and Pharmaceutical Regulatory requirements, to scientists and other professionals who operate in the ‘Quality Environment’ of the bio/pharmaceutical industry (accounting for up to 25% of graduates in this sector).

There are more than 85 pharmaceutical companies in Ireland with 9 of the world’s top 10 pharma companies having substantial operations here. The programme is tailored to those who wish to work in this sector.

The programme provides an industry-relevant, broad-based curriculum which focusses on the Quality and Regulatory Framework for the bio/pharmaceutical industry.

The programme is flexibly designed to provide the knowledge, skills and competence required to work in the area of Quality Assurance. TU288 is offered on a two-year part-time basis. It is designed to consolidate, supplement and enhance the knowledge and experience of graduates currently employed in the pharmaceutical sector. It is aimed at those wishing to further their studies in aspects of quality assurance, regulation and validation.

The programme is divided into two stages – stage 1 and stage 2.

Stage 1 - The taught part of the programme (nine modules), is delivered to students on a part-time basis over two years. Students undertake the nine modules over 4 semesters. All modules are assessed by assignment.

Stage 2 - On successful completion of the nine modules, students undertake a 6 months industrial based dissertation while working in their place of work.

The programme is delivered online. However, attendance at scheduled workshops will be required.

The following modules are currently offered:

• Pharmaceutical Microbiology and Aseptic Manufacture (Drug Product)
• Pharmaceutical Quality Assurance & Research Methods – 10 ECTS
• Pharmaceutical Regulation, Validation and Statistics – 10 ECTS
• Biopharmaceutical Manufacture (Drug Substance)
• Process Technologies (Process, Facilities, Equipment & Utilities) 10 ECTS
• Quality Risk Management
• Pharmaceutical Manufacturing & Management
• Advanced Therapeutics & their Regulation
• Innovative Medicines & their Regulation

Note: There are three 10 ECTS modules as indicated above, the remaining six modules are 5 ECTS.

Students will normally have an average of seven contact hours per week, comprising lectures, case studies and discussion sessions. The modules are normally delivered on 2 evenings and a Saturday morning each week over the course of the semesters.


Applications open from Monday, 23rd November 2020.
TU Code



NFQ Level 9




2 years

Course Type


Mode of Study

Part Time

Method of Delivery


Commencement Date

September 2021


City Centre: Grangegorman



Contact Us

Dr Fiona O'Sullivan

Contact Us

MSc Administrator, Alex Velto