This course is right for you if;
Minimum Entry Requirements
PhD, Masters or a Degree in the following:
- Biochemistry
- Biotechnology
- Cell Biology/Molecular Biology
- Chemistry
- Immunology
- Microbiology
- Laboratory Science
- Any other Biological Science
- Any other Chemical Science
AND YOU MUST
- currently work in the field
OR - have worked or graduated in this field within the last 2 years
If not, check out our University Certificate in eBioPharmaChem
What kind of 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
- 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
- QC Analyst, QC Scientist
- QC Microbiology Analyst
- QC Drug Product Technologist
- QC Specialist -LIMS
- QC Biochemist UA
Science roles that support manufacturing – Typical roles support the manufacturing process in a regulated environment and work within multidisciplinary teams to produce medicinal products.
- Microbiology/Particle Analyst
- Process Sciences Manager-Upstream
- Environmental Microbiologist
- Bioprocessing Scientist
- Production Scientist
- Senior Scientist Technical Support
- Process Scientist / Specialist – Purification
- Process Scientist / Specialist – In-Process Control
Science roles in development is the “D” part of “R&D”. Development is the phase after research where the creation of a proven drug is moved from the lab to the manufacturing plant.
- Tech Transfer Scientist Jobs
- Process Technology Transfer Scientist
- Transfer Scientist
- Product and Process development scientists
But for specialist advice based on your own science degree subject, click on one of the links below:
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, QC or science roles in development or manufacturing using the relevant tools and techniques you have learned.
And take the following skills and knowledge to your new career
- You’ll have enough technical knowledge and understanding of the quality culture necessary to work in quality assurance roles, quality control roles, science roles that support manufacturing or science roles in development 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.
