Process Validation & Regulatory Affairs - Limerick

Many companies operate in highly regulated areas where the demand for dynamic validation engineers, effective quality management systems and regulatory compliance leaders is growing in the Pharmaceutical industry. 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 p

Subjects taught

What modules will I study?

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

Entry requirements

(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

Duration

1 year

Post Course Info

Are there opportunities for further study?
Students can progress to an appropriate Masters or PHD

What are the career prospects?
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

More details
  • Qualification letters

    MSc

  • Qualifications

    Degree - Masters (Level 9 NFQ)

  • Attendance type

    Part time

  • Apply to

    Course provider