Program Overview

BA (Hons) In Pharmaceutical Business Operations

Overview

This Honours degree course in Pharmaceutical Business Operations is the only pharma course of its type on offer in Ireland. This course is delivered in partnership with Innopharma.

Course Details

This course is delivered over two years. Students have the option to enter at Year 1 or Year 2 depending on their prior qualifications.

Year 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
• Management & Organisational Behaviour
  • Organisational structure and design
  • Organisation culture and change
  • Management & leadership
  • Organisational control and power
  • Work groups and teams in organisations
• Operations Management
  • Operations management
  • Sales & operations planning
  • Planning control and improvement
  • Performance measurement
  • Operational governance
• 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
• 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
• Control Systems and Real-Time Analytics
  • Control and data management systems
  • System development lifecycle
  • Process analytical technologies
  • Real-time control system
  • Critical quality attributes
• 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
• Career Progression
  • Fundamentals of developing a successful CV
  • Cover letters
  • Presentation and communications skills
  • Networking
  • Interviewing skills
  • Personal coaching & mentorship

Year 2

• Pharmaceutical Quality Management Systems
  • Pharmaceutical quality systems
  • Validation
  • Change control
  • Investigations
  • Audit performance
  • Annual product reviews (APR)
  • Quality metrics
  • Quality risk management
• Pharmaceutical Manufacturing & Distribution
  • Biopharmaceutical manufacturing overview
  • Pharmaceutical packaging
  • Good distribution practice
  • Product release
  • Falsified medicines directive
• Strategic Management
  • Introduction to strategic management
  • Scanning the environment
  • Strategy formulation
  • Strategy implementation & change management
  • Evaluation and control
• Clinical Research
  • Drug development lifecycle
  • Phases of clinical research
  • Primary regulations & directives
  • GCP auditing/pharmacovigilance
  • Clinical pharmacology
• Project Planning & Finance
  • Project management
  • Project initiation & conceptualisation
  • Project scheduling and time management
  • Project budgeting/costing
  • Project closure & communication
  • Project leadership & communication
  • Risk management
• Professional & Technical Communications
  • Career preparation skills
  • CV development
  • Interview skills
  • Technical communications

Timetables

This two-semester programme is delivered two evenings a week and two Saturdays a month.

How to Apply

Entry Requirements

Applicants must hold a minimum qualification at NFQ Level 7 in science, engineering, quality or a related discipline. Recognition of prior learning may also be taken into account.

English Language

Griffith College is accepting the online Duolingo English Test (DET) as valid proof of English proficiency.

Fees

Tuition Fees

• Irish/EU citizens, living in Ireland
  • Study Mode: Part-Time
  • Dublin: EUR 5,250.00
• International
  • Study Mode: Part-Time
  • Dublin: Non-EU living in Ireland or abroad: Please refer to our Non-EU Tuition Fees section.

Progression

Academic Progression

Graduates of the BA (Hons) in Pharmaceutical Business Operations may be considered eligible to join related Masters Degree programmes such as the MSc In Pharmaceutical Business and Technology.

Career Progression

Graduates of the BA in Pharmaceutical Business Operations are well positioned to pursue a range of careers including:

• Manufacturing Operator / Supervisor
• Compliance Specialist
• Business Improvement Specialist
• Quality Assurance
• Validation Specialist
• Data Analytics
• Clinical Trial Coordination