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  • Location

    Dublin

    Cork

  • Duration

    9 months

  • Level

    Degree / Higher Diploma

  • Next Intake

    Feb 2022

Course overview

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.

This BA (Hons) in Pharmaceutical Business Operations developed by Innopharma Education in conjunction with Griffith College is suitable for those with a higher certificate in science, engineering or a related discipline who are looking to start a new career or develop an existing one. Designed and delivered by highly experienced academics and industry professionals, you will learn the skills and knowledge that companies are looking for. 

This course is delivered part-time and lectures are broadcast live online giving you the opportunity to join the class online if for some reason you cannot attend class in person. The modules are also recorded which means you can view them at a later stage.

Accreditation: QQI Level 8 BA Honours Degree in Pharmaceutical Business Operations. 

Awarding body: Griffith College Dublin

Next Intake: September 2021

Innopharma Student

Course Outline

This course is delivered over 2 years. Students have the option to enter at year 1 or year 2 depending on their prior qualifications. (ECTS: 120 Credits)

Year 1

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

Organisational structure and design; organisation culture and change; management & leadership; organisational control and power; workgroups and teams in organisations

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 cGMP 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

Year 2

Module 1: Pharmaceutical Quality Management Systems 

Pharmaceutical quality systems; validation; change control; investigations; audit performance; annual product reviews (APR); quality metrics; quality risk management.

Module 2: Pharmaceutical Manufacturing & Distribution

Biopharmaceutical manufacturing overview; pharmaceutical packaging; good distribution practice; product release; falsified medicines directive.

Module 3: Strategic Management

Introduction to strategic management; scanning the environment; strategy formulation; strategy implementation & change management; evaluation and control. 

Module 4: Clinical Research

Drug development lifecycle; phases of clinical research; primary regulations & directives; GCP auditing/pharmacovigilance; clinical pharmacology.

Module 5: Project Planning & Finance

Project management; project initiation & conceptualisation; project scheduling and time management; project budgeting/costing; project closure & communication; project leadership & communication; risk management.

Module 6: Professional & Technical Communications 

Career preparation skills; CV development; Interview skills; technical communications.

Lecturer

Entry Requirements

This course is suited for those with a minimum qualification of Certificate at QQI Level 7 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.

HOWEVER. students who wish to apply for Human Capital Initiative (HCI) funding, require any existing Level 8 Honours Degree. 

 

QQI Levels Explained


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

The options for further study upon successful completion of this course could include progression to the following postgraduate 9 courses,

  • MSc in Pharmaceutical Business & Technology
  • PGDip in Medical Device Technology & Busines

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 by 2020
Tablet Manufacturing 
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Testimonials

Testimonials

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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

Our graduates are now working in…

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