Process Validation & Regulatory Affairs - Pharmaceutical - Limerick

The programme will enable an understanding of all current applicable regulations, quality management systems and effective process validation requirements. Learners will have the knowledge and skills to audit all, or part of, the organisation's formal Quality Management systems. Acquire the ability to objectively evaluate evidence generated by systems and processes against clearly defined criteria and determine the effectiveness of these systems and processes; ensuring that learners will develop skills to address and prepare for the ever-changing environment of regulatory affairs in the Pharmaceutical sector.



Critical thinking, problem solving, decision making, professionalism and management techniques will be key areas covered by the programme.



There will be a total of 14 hours per week. Ten hours of classes will take place on campus on Wednesday and Thursday. Four hours will be delivered online on Mondays.

Semester 1 - September - December

Advanced Process Engineering Credits: 10

Quality Management Credits: 10

Regulatory Affairs (Pharmaceutical) Credits: 10

Dissertation (Yearlong) Credits: 30



Semester 2 - January - May

Advanced Regulatory Affairs (Pharmaceutical) Credits: 10

Auditing and Risk Management Credits: 10

Process Validation Credits: 10

Dissertation (Yearlong) Credits: 30

(a) A minimum honours bachelor degree (Level 8) in any discipline with minimum, relevant work experience and/or ability, evidenced by an RPL portfolio of prior experience and learning.



Or



(b) A minimum ordinary bachelor degree (Level 7) in any discipline with minimum two years relevant work experience and/or ability, evidenced by an RPL portfolio of prior experience and learning.



Or



(c) Equivalent Qualifications. Applicants with equivalent qualifications on the European and International frameworks will also be considered. International students must evidence a proficiency in English language for example IELTS 6.5

Application deadline: Early applications up to May 1st 2024 will be accepted and processed.

Late applications will be considered up to August 31st 2024 where places are available.

1 year

PROGRAMME START DATE: The programme will commence in early September on the same date as all TUS semesterised Programmes. Please consult the Academic Calendar on the TUS website - https://tus.ie/registry/academic-calendar/

Location: Moylish Campus, Limerick

Further Study

Upon successful completion of this programme, graduates have the opportunity to complete Level 9/10 programmes here at TUS or elsewhere.



Career Opportunities

This programme has been designed to meet the growing requirements of pharmaceutical companies in filling Quality, Validation, Management, Auditing, Compliance, Legal and Regulatory affairs.. The motivation for developing this programme emerged from industry needs, gaps in education programms and a lack of graduates in the hiring pool. The content has been developed jointly by TUS in conjunction with industry consultants and industry practitioners from companies such as Abbott, BD Medical, Johnson & Johnson, Regeneron, Edward Science, Boston Scientific etc.



There are multiple roles a graduate from the programme can seek in disciplines such as Validation, Management, Auditing, Compliance, Legal and Regulatory affairs.



Career Opportunities Include:

Regulatory Affairs Specialist / Engineer / Manager

Verification and Validation Specialist / Engineer /Manager

Quality and auditing Specialist / Engineer / Manager

Compliance Specialist / Engineer / Manager

Verification and Validation Specialist / Engineer /Manager

Manufacturing or Process Engineer/ Manager