This Course is Right For You If;
Minimum Entry Requirements
You currently work OR have worked or graduated within the last 2 years in any one of the following…
- Quality Control or Quality Assurance in:
- Medical device
- Nutritional
- Beverage
- Food
- Dairy manufacturing
- Food Science qualification or work in the food science sector
- Pharmacist/Diploma of Pharmacy
- Pharmacy Technician
- Pharmacology
If not, check out our University Certificate in eBioPharmaChem
If you have a quality background in engineering/manufacturing, check out our Conversion Course into Engineering Roles in Pharma.
What Kind of Quality Control or Quality Assurance Jobs Could I Get?
Depending on your previous experience, here are some of the most common job titles we see advertised;
Quality assurance is process-oriented and focuses on removing any variation from the processes of manufacturing. The role tends to be detail-orientated and documentation-focused.
- Quality Assurance Specialist
- Quality Assurance Associate
- Quality Associate Manager
- Plant Quality Assurance Senior Associate
- QA Specialist – Raw Materials
- QA Compliance Specialist
- QMS/QA Specialist
- QA Internal Auditor
- QA Compliance Manager
- Quality Systems Coordinator
Quality control is product-oriented and focuses on testing samples from the manufacturing process to make sure they meet the required specifications and standards.
- Quality Control Microbiology Analyst
- Quality Control Specialist,
- Quality Control Analyst FTC
- Senior Quality Control Analyst
- QC Analyst, QC Scientist
- QC Micro Technician
- QC Microbiology Analyst
- QC Drug Product Technologist
- QC Specialist -LIMS
- QC Biochemist UA
Enrol in this course to learn…
- Introduction – to pharmaceutical, (bio)pharmaceutical manufacturing in a GMP (Good Manufacturing Practice) regulated environment, quality systems vs regulation vs validation.
- Quality Risk Management (QRM) – the huge importance of risk management and the steps involved in its application.
- GMPs vs Quality Management Systems – GMPs vs ISO 9001:2015 and why use them both.
- Industry Regulations and Guidelines – including, FDA GMPs for the United States, EMA GMPs for European Union, ICH, and PICs GMP regulation
- Good Automated Manufacturing Practices (GAMP) – software categories, scalable validation deliverables, and operation activities.
- API Manufacturing Technologies – organic chemical synthesis, aseptic & sterile manufacturing, separation technologies, and multi-stage sequence API synthesis.
- Biopharmaceutical Manufacturing Technologies – upstream processing, fermentation cellular protein synthesis, downstream processing, and column chromatography.
- Process Validation and Documentation – design and verification of manufacturing systems
- Cleaning Validation – engineering and chemical aspects of cleaning and cleaning equipment
- Key Manufacturing Technologies – tablet manufacturing, vial filling, and freeze-drying FDA vs EU medical device regulations and classification.
- Equipment Validation – IQ OQ PQ and Baseline Guide 5.
- Advanced Career Coaching – Advanced course on how to find a job in the pharma sector.
You’ll produce a number of deliverables throughout the course including…
- Complete 8-question booklets (one for every week’s worth of content) which will summarise what you have learnt for the week and ensure you retain and understand the information.
- Complete 7 Quality Risk Management workshops on:
- Fault Tree Analysis (FTA)
- Cause and Effect Analysis
- Failure Mode Effect Analysis (FMEA)
- Preliminary Hazard Analysis (PHA)
- Hazard Operability Analysis (HAZOP)
- Event Tree Analysis (ETA)
- Hazard Analysis and Critical Control Points (HACCP)
- Complete an end of module 10 page essay assignment on “Why cGMPs are required for the manufacture of a life sciences product”.
- Complete a 9-step application process simulation for a QA or QC job, using the relevant tools and techniques you have learned.
And take the following skills and knowledge to your new job
- You’ll have enough technical knowledge and understanding of the quality culture necessary to work in quality assurance and or quality control roles in this environment.
- You’ll have a solid understanding of how safe medicines and medical devices are made in a regulated GMP environment.
- You’ll have a foundational understanding of GMPs, Industry Regulations and Guidelines, Quality Risk Management Tools, GAMP, Equipment and Cleaning Validation
- You’ll be able to participate in root cause analysis and quality risk management (QRM) projects.
- You’ll be able to work with professionals in this sector without feeling lost or intimidated by the specialised terms and frameworks used in this sector.
