Courses in

Biopharmaceutical and Medical Science

Bachelor of Science in Quality for Industry (Add-On ) Honours Degree

Open for Applications

Discipline: Biopharmaceutical and Medical Science

Location: Galway - Dublin Road

NFQ Level: 8

Programme Duration: One year

Mode of Study: Part time

Application Route: Apply direct to GMIT

Entry Requirements: Level 7 Degree in Quality or equivalent

Places: 25

Programme Modules

  • Statistics and experimental design (10 credits @Level 8)
  • Quality management systems & frameworks (5 credits & Level 8)
  • Regulatory affairs (5 credits@ Level 8)
  • Technical writing withcase studies (5 credits@ Level 8)
  • Design quality assurance (5 credits & Level 8)
  • Quality management operational excellence (10 credits @ Level 8)
  • MIcrobial quality assurance (5 credits @ Level 8)
  • Risk management (5 credits @ Level 8)
  • Research project (10 credits @Level 8

The course schedule is:

YEAR 1 (Starting in September 2018)

  • Semester 1 Statistics and experimental design 10
  • Semester 1 Quality management systems & frameworks 5
  • Semester 1 Technical writing with case studies 5
  • Semester 2 Statistics and experimental design 10 (contd)
  • Semester 2 Design Quality Assurance
  • Semester 2 Regulatory Affairs

YEAR 2: (Also starting in September 2018)

  • Semester 1 Quality management operational excellence 10
  • Semester 1  Microbial quality assurance 5
  • Semester 1  Risk management 5
  • Semester 2 Quality management operational excellence 10 (contd)
  • Semester 2 Research project 10

Module Aims: 

The purpose of the  degree is to offer a structured, flexible and progressive programme of study to students.

The programme seeks to:

  • Provide students with a broad, integrated approach to quality management, facilitating their progression in a quality role in industry or services.
  • Provide students with the ability to develop and implement various quality systems which would lead to an accredited quality award.
  • Provide the leadership and communication skills required to work at senior level in the area of quality and to effect change.
  • Facilitate the students in developing expertise in various quality tools that cover the life cycle of various products and services.

Learning Outcomes: 

On successful completion of this programme the learner will have detailed knowledge of:

  • The regulatory framework governing the development and production of regulated    products, particularly pharmaceuticals and medical devices.
  • Quality management frameworks and standards.
  • The interpretation of regulations and Good Manufacturing Practice guidelines for the pharmaceutical, bio-pharmaceutical, medical device sectors and other regulated industries
  • The role of quality managers and quality supervisors in promoting and managing quality within an organization.
  • Specific statistical process control tools that are used to identify quality issues.
  • Management systems and laboratory practices associated with the management of cleanrooms and the control of sterilization processes.
  • The use of auditing techniques to identify non-compliance issues.

Essential Information: 


10% of normal fees for first 40 credits. See "Quality for the Medical Device Industry" course on

Student Cards

Students who enrol for this Certificate will qualify for issuing of a GMIT Student ID Card.


Year 1:

  • Wednesdays from September 2018 to May 2019, from 18:30 to 22:00, commencing Wednesday 19 September 2018
  • Thursdays from September 2018 to May 2019, from 18:30 to 22:00, commencing Thursday 20 September 2018

Year 2: 

  • (Evening TBD) from September 2018 to May 2019, from 18:30 to 22:00, commencing Wednesday 19 September 2018
  • (Evening TBD) from September 2018 to May 2019, from 18:30 to 22:00, commencing Thursday 20 September 2018

The timetable for Year 2, commencing in September 2018, is:

Statistics & Experimental Design Wednesday 6.30 PM -10 PM
Quality Management Systems & Frameworks Thursday 6.30 PM -10 PM
Tech writing & case studies Wednesday and Thursday (6.30 PM-10 PM)

Entry Requirements

The Level 8 degree in Quality for Industry was designed as an add-on to the Level 7 award in Quality for Industry. If you hold the Level 7 degree in Quality for Industry, then you are eligible to apply for the Level 8 degree. If you hold a different Level 7 qualification then this will be assessed to determine if it is a suitable Level 7 qualification for admission.  Relevant, technical work experience in the medical device / pharma sector will be taken into account in this assessment.

The course is delivered in the GMIT Galway Campus, Dublin Road, Galway. The room will be advised on the Notice Board in Reception on the first night.

Closing Date for Applications

Application Process
You must apply on

Contact Us


Emily King

School of Science

GMIT, Dublin Road





Peter Butler

Lifelong Learning Centre

GMIT, Dublin Road


Phone: +353 (0)91 742328