This Course is Right For You If;
You already have a PhD, Masters or a Degree and don’t want to spend huge amounts of your time or money getting another university qualification at the same or much lower level.
You work in academia or a research laboratory and want to move into the high paying manufacturing sector.
Minimum Entry Requirements
Any one of the following…
- You work in Quality Control or Quality Assurance in:
- Medical device
- Nutritional
- Beverage
- Food
- Dairy manufacturing
- You have a Food Science qualification or work in this sector
- Pharmacist/Diploma of Pharmacy
- Pharmacy Technician
- Pharmacology
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.
Hear From People Who’ve Taken This Course
John Ryan
“The course content material is concise and interesting”
“The professionalism and passion of the lecturers comes across in the tutorials which gives the student confidence and encouragement to keep on top of the course. The course content material is concise and interesting. The timing of the release of the lessons is perfect, the student moves at a comfortable pace, one step at a time.”
Ronan Balfe
“I would have no hesitation in recommending these courses”
“Studying online gives you the time to do the course in your own time yet with assignment deadlines this made you disciplined to meet the deadlines set. I would have no hesitation in recommending these courses to anyone wishing to gain an education in the pharmaceutical sector.”
Edel Harkins
“Highly recommended to anyone who has been out of the industry for a period of time”
“I would highly recommend anyone in my situation who has been out of the industry for a period of time to do these courses. They have contributed to my new found confidence in my existing and new qualifications, my improved interview skills and my new job!”
We’ve got lots more success stories like these. Read ‘em, or try GetReskilled and see the difference yourself.
Your 15-Week Class Schedule
Module 1 – Fundamentals in Pharmaceutical Manufacturing (Weeks 1-10)
This module was developed in consultation with the pharmaceutical manufacturing industry including Pfizer and MSD.
Module 2 – Advanced Career Coaching (Weeks 11-15)
Delivered by a Practicing Industry Expert
Dr. Joe Brady
Full-Time Validation Lead
Lecturer, Technological University Dublin, Ireland
Senior Associate, GetReskilled
Dr. Joe Brady is a full-time practicing Validation Lead and an assistant lecturer with Technological University Dublin (TU Dublin), in the School of Chemical and Pharmaceutical Sciences. Joe is a certified trainer and highly experienced in competency-based training. He designs and prepares educational modules and full academic courses ranging from MSc, MEngSc. BSc, to Certificate level, for a range of academic institution.
He is also a supervisor for MSc/MEngSc and PhD theses. Joe has over twenty years of project experience in the pharmaceutical, biopharmaceutical, and medical device industries in Ireland, Singapore, China, The Netherlands, France, and the USA.
If you’re spending money on an education program, make sure you choose one you’ll finish!
With every GetReskilled ONLINE program;
- We use one centralized platform (Moodle) where you can log into your classroom anytime. Each week, you’ll watch videos and complete a series of quizzes, tests, interactive activities, and projects. The course materials are available 24/7 and nothing requires you to be online at a specific day or time. i.e there are NO ZOOM classes and NO WEBINARS! Study anywhere, anytime, for example after the kids have gone to bed or on the weekend.
- Your working schedules are unpredictable so we offer flexible delivery. Slow down, speed up or pause the delivery of the program.
- We release only one week’s worth of material at a time and then MANUALLY check your activity logs at the end of every week to make sure that you are keeping up with your work.
- You’ll have a dedicated course leader who will email or telephone you if it looks like you’re starting to fall behind. They will work with you to develop a study plan to get you back on schedule and finish the course.
This all helps us to spot any potential issues early and helps you completely finish the program.
Show Off Your New Skills: Get a Certificate of Completion
Once the course is over, complete a written assignment to get certified in The Fundamentals of Pharmaceutical Manufacturing Technologies
Add details of your certificate to your CV/Resume or your LinkedIn profile.
11 Frequently Asked Questions
Yes, this program is delivered fully online so you can learn from home (or anywhere). Study after the kids have gone to bed.
No, this program is aimed at those who already have a degree in the laboratory sciences and want to retrain for a job in the pharma sector (and start making money) as quickly as possible without having to go to the extra time, effort and expense of getting another university qualification.
However, if you would like to cover the same material and get a university qualification, the program’s core content is also covered in the first module of our 3 module Certificate in eBioPharmaChem.
There are a total of 15 sessions of online content, one per week. Each session of online content typically includes 6-10 topics.
Each topic includes:
- A set of course notes – these provide additional depth to the video content.
- Warm-up self-assessment question – to recap or activate any relevant prior learning.
- A video – these are typically 5-10 minutes long and deliver 80% of the course content.
- Post video self-assessment questions to check how well you can recall this new material from memory.
- Any follow up assessments or assignments.
We release only one week’s worth of material at a time and then check your activity logs weekly to make sure that you’re managing to keep up with your workload. This helps us to spot any potential issues early. There is a “Progress Bar “on your course which is helpful to you and us to know how you are doing.
You have a dedicated course leader who will follow up with you if it looks like you’re starting to fall behind. She’ll also be in touch weekly to let you know when new content is open for you.
Yes, you can speed up or slow down the rate of delivery to suit your requirements. The most important thing is communication between you and your course coordinator.
If you are taking a break or are busy at work and do not have time to study you need to tell her or him. Similarly, if you want to study at a faster rate, then just email in good time and ask for more course content.
No, I’m afraid we can’t do that.