Course Description
Certificate in Quality and Regulatory Practice in the Pharmaceutical Industry
Why Study Quality and Regulatory Practice at Griffith College?
The Certificate in Quality and Regulatory Practice in the Pharmaceutical Industry is designed to give you the specialist knowledge and practical skills needed to succeed in one of the world’s most highly regulated and fast-growing sectors.
This programme bridges the gap between science, quality, and regulation, helping you understand how safe and effective medicines are developed, approved, and brought to market.
What will you learn?
Through this programme, you will:
- Understand the critical role of quality in ensuring safe and effective medicines
- Learn how quality systems apply across development, manufacturing, and supply
- Gain insight into the full regulatory lifecycle – from discovery and clinical trials to approval and release
- Explore the real cost of poor quality and how to prevent it through effective risk management
- Develop knowledge of Good Manufacturing Practice (GMP) and continuous quality improvement
- Understand how pharmaceutical products evolve and are managed throughout their lifecycle
Why it matters for your career
Quality and regulatory expertise is in high demand across the pharmaceutical industry. This programme equips you with job-ready skills that are directly applicable in roles across quality assurance, regulatory affairs, and manufacturing.
Why work in the pharmaceutical industry in Ireland?
Ireland is a global leader in the pharmaceutical and biopharma sector, offering exceptional career opportunities:
- Global presence: All of the world’s top 10 pharmaceutical companies operate in Ireland
- Strong employment: Over 30,000 people are employed directly in the biopharma industry, with thousands more supported indirectly
- Economic impact: Pharmaceutical and medical products account for around 30% of Ireland’s total exports
- Global ranking: Ireland is the 3rd largest exporter of pharmaceuticals worldwide
The Certificate in Quality and Regulatory Practice in the Pharmaceutical Industry course at Griffith College Cork is listed in Courses.ie's national courses finder.
| Training Provider | Griffith College Cork |
| Course Location | Cork |
| Course Type | In-Person Training |
| Course Qualification | Special Purpose Award / Certificate |
| Awarding Body | QQI |
| Awarding Body Details | Special Purpose Award |
| Course Duration | 1 semester |
| Course Fee | €1,240 |
| Entry Requirements | Entry Requirements Candidates seeking access to the Certfiicate in Quality and Regulatory Practice programme are required to hold either: A Level 8 Honours Degree, 2.2H or higher, in Pharmacy, Science, Business or equivalent discipline. A level 8 Honours Degree, 2.2H or Higher, in a non-business related discipline, with the following conditions: - Candidates with significant business/management experience may apply through our APEL route, in line with college policy. - Candidates who have no management experience will be assessed as to their prior learning. Where appropriate, candidates will be directed to take an additional module during semester one: Finance for Non-Financial Managers(PDF file). A level 8 Honours Degree, 2.2H or higher, in a business related non-STEM discipline, with the following conditions: - Candidates with significant pharmaceutical experience may apply through our APEL route, in line with college policy. - Candidates who have no pharmaceutical experience but who hold a business-related degree will be assessed as to their prior learning. Where appropriate, candidates will be directed to take an additional module during semester one: Introduction to Pharmaceutical Industry(PDF file). This module is intended to prepare learners from general business backgrounds for the pharmaceutical learning outcomes during this MSc programme. Applicants over the age of 23 may apply on the basis of previous work experience and a demonstration of commitment to further studies (Applicants under the age of 23 are required to meet the minimum entry requirements). Each candidate’s application will be considered individually in accordance with the College’s QQI approved quality assurance procedures. Candidates holding relevant alternative qualifications and those with related experiential learning will be considered under the College’s RPL policy. English Language All learners are also expected to be proficient in the use of the English language. Where a candidate’s mother tongue is not English, he/she will be required to provide proof of proficiency in the English language through satisfactory performance on an internationally recognised test (e.g. TOEFL 575, IELTS 6.5 or other similar English language qualifications). Griffith College is accepting the online Duolingo English Test (DET) as valid proof of English proficiency. Please see here for further details. How to Apply Students who wish to apply for this course may apply directly to Griffith College. They should have obtained a degree at least a level 8 honours degree in pharmacy, science, business or related discipline. When our Admissions team receive your application they will be in contact with you directly. |
| Career Path | Students who complete this course may proceed onto another Pharmaceutical Business Management course at Griffith College, including MSc in Pharmaceutical Business Management Postgraduate Diploma in Pharmaceutical Business Management The skillset needed to work in a modern biopharma plant is evolving with the growing importance of biologics products. These skills are highlighted in Ireland’s National Skills Strategy 2025, where regulatory compliance and pharma co-vigilance roles are in demand by the industry. Progression from this programme could include (depending on prior experience): Clinical - Regulatory Associate CMC (Chemistry, Manufacturing, and Controls) Regulatory Associate Regulatory Affairs Specialist |
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