- Overview
- Course outline
- Entry
- Career path
- How to apply
Course Overview
This programme is year one of our 2 year Honours Degree in Pharmaceutical Business Operations. This part-time online course will help you gain expertise in manufacturing, science, regulation quality, technical writing, lean operations and team leadership skills.
The pharmaceutical industry has traditionally required individuals with a strong science or engineering background to support its significant manufacturing activities in Ireland. Today, there is a new skill set required along with those with scientific knowledge. This skill set requires professional individuals with a strong knowledge of manufacturing, compliance, regulation as well as business improvement. These skills need to be supported with an ability to assimilate information, make effective decisions and communicate clearly using the latest technologies and systems. Learn more about how industries are changing here.
It is suitable for those who wish to develop their career in the areas of pharmaceutical operations, compliance, business improvement, technology transfer, validation, clinical trials and data analysis. With extensive input and participation from the pharmaceutical and clinical trials sectors, this programme is ideal for those involved in manufacturing, compliance, business improvement, quality assurance, validation, data analytics and clinical trial coordination.
Modules Include:
- Pharmaceutical Manufacturing
- Management & Organisational Behaviour
- Operations Management
- Regulatory Affairs & Validation
- Operational Excellence – Lean Sigma
- Control Systems & Real-Time Analytics
- Clinical Research Co-ordination
- Career Development
This course is delivered through blended learning, 2 evenings per week online and up to 2 Saturdays per month in person.
Accreditation: QQI Level 7 BA in Pharmaceutical Business Operations.
Collaborating College: Griffith College Dublin
Next Intake: February 2025. Now accepting applications.
Course Outline
This course is the first year of our Honours Degree in Pharmaceutical Business Operations programme which is delivered over 2 years (ECTS: 180 Credits)
Module 1: Pharmaceutical Manufacturing
Pharmaceutical dosage forms; drug product formulation and their chemical function; pharmaceutical manufacturing processes; quality control release testing requirements; stability testing; process validation; change control
Module 2: Management & Organisational Behaviour
Operations management; sales & operations planning; planning control and improvement; performance measurement; operational governance
Module 3: Operations Management
Operations management; sales & operations planning; planning control and improvement; performance measurement; operational governance
Module 4: Regulatory Affairs & Validation
Regulatory requirements for pharmaceutical manufacturing; distribution and clinical trials; elements of typical cGXP quality systems; clinical trials; pharmaceutical manufacturing; pharmaceutical distribution; marketing authorisation application; current trends in cGMP.
Module 5: Operational Excellence – Lean Sigma
Lean thinking; six sigma; project planning; process mapping; root cause analysis; creative solutions; corrective action preventative action; statistics; data visualisation; presentation skills; effective decision making
Module 6: Control Systems and Real-Time Analytics
Control and data management systems; system development lifecycle; process analytical technologies; real-time control system; critical quality attributes
Module 7: Clinical Research Co-Ordination
Research & development process; clinical studies; statistical concepts in a clinical study; drug safety system; regulations & directives applicable to clinical trials; GCP inspection; clinical study reports & clinical overview
Module 8: Career Progression
Fundamentals of developing a successful CV; cover letters; presentation and communications skills; networking; interviewing skills; personal coaching & mentorship
Entry Requirements
This course is suitable for those with a qualification of a Higher Certificate at QQI Level 6 (120 credits) or higher in Science, Engineering, Quality or a related discipline who wish to develop their knowledge and skills on the application of science in the Pharmaceutical industry. Where appropriate, recognition of prior learning (RPL) and experience may support entry onto this programme. Traditionally we have had significant success in using the RPL option for this programme.
Career Options
Potential career opportunities following the successful completion of this course are highlighted below:
- Manufacturing Supervisor / Manager
- Supply Chain Planner
- Clinical Trials Coordinator
- Business Improvement Specialist
- Lean and Six Sigma
- Compliance Specialist
- Process Improvement Specialist
- Project Co-ordinator
- Pharmaceutical Operations
Academic Progression
On successful completion of the Level 7 Degree Programme, students can progress to a fully QQI Level 8 Honours Degree in Pharmaceutical Business Operations.
Apply Now
Our admissions team are on hand to assist you with your application and answer any questions you may have on the course.
Students who wish to apply to this course should follow the following application process.
Step 1: Enquire through the form at the top right of this page
Step 2: A member of our team will be in contact through phone or email
Step 3: If you are deemed to be eligible for the course, you will be sent an application form by email. You MUST fill in this application form and attach all necessary *documents (CV, ID, Transcripts, etc.)
Step 4: On submission of the completed application form and all documentation, your application will be sent to the associated department for final approval. You will receive an e-mail confirming your place on the programme. (Note: This process can take up to one week particularly during busy admission periods.)
*We accept scanned documents in a pdf format. Pictures of documents are not accepted.
**For those who are applying for Springboard or HCI funding, you will be directed to fill out an additional application form on the Springboard website, this is to confirm your eligibility to receive funding
Please note at any time if you have any questions please do not hesitate to contact us by email on admissions@innopharmalabs.com or call us (01) 485 334
Why up-skill for the pharmaceutical industry in Ireland?
- €3 billion in new capital investment
- €39 billion in exports
- Over 55,000 employed
- 9 of top 10 world’s biopharma companies in Ireland
- 12 of the top-selling drugs made in Ireland
- Over 8,000 new jobs predicted
Testimonials
There is content in every module that I use as part of my job every day
BA in Pharmaceutical Business Operations Graduate, Sabrina Mitchell, People Team Lead in GE Healthcare
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