Program Overview

Process Validation and Regulatory Affairs (Pharmaceutical) – MSc

Overview

The MSc in Process Validation and Regulatory Affairs is designed to equip learners with competence in the appropriate legal, compliance, and industry operational standards. The program focuses on the pharmaceutical industry, covering quality management systems, process validation requirements, and regulatory compliance.

Course Details

• Location: Moylish, Limerick City
• Duration: 1 year
• Level: 9
• Course Type: Postgraduate
• Study Mode: Full Time
• Department: Mechanical & Automobile Engineering

Entry Requirements

• A minimum honors 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.
• 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.
• 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.

Course Modules

• Semester 1 (September to December)
  • Advanced Process Management (10 credits)
  • Quality Management (10 credits)
  • Regulatory Affairs (Pharmaceutical) (10 credits)
  • Dissertation (Yearlong) (30 credits)
• Semester 2 (January to May)
  • Advanced Regulatory Affairs (Pharmaceutical) (10 credits)
  • Auditing and Risk Management (10 credits)
  • Process Validation (10 credits)
  • Dissertation (Yearlong) (30 credits)

Career Opportunities

This program has been designed to meet the growing requirements of pharmaceutical companies in filling Quality, Validation, Management, Auditing, Compliance, Legal, and Regulatory affairs roles.

• Regulatory Affairs Specialist/Engineer/Manager
• Verification and Validation Specialist/Engineer/Manager
• Quality and Auditing Specialist/Engineer/Manager
• Compliance Specialist/Engineer/Manager
• Manufacturing or Process Engineer/Manager

Further Study

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