Quality, Pharmacy or Food Science Background? Retrain ONLINE for Quality Control or Quality Assurance Roles in Pharma Manufacturing in 15-Weeks

Take our “Conversion Course into Quality Roles in Pharma”. Quickly learn all you need to successfully move into Quality Assurance or Quality Control roles in Pharmaceutical manufacturing from a different industry. Core content developed in consultation with the industry including Pfizer and MSD.

Estimated salaries €39,000 – €80,000 plus overtime, bonuses and allowances. (Based on Irish job data)

Estimated salaries $39,000 – $95,000 plus overtime, bonuses and allowances. (Based on US job data)

Get from your current industry to working in a quality assurance or quality control role in the Pharma and Medical Device industry as fast as possible.
Start your path to a well-paid and rewarding career in pharma manufacturing
Learn how safe medicines are made using GMPs
Application Deadline: Wednesday 25th May

Study Online part-time – complete 2 modules
12 hrs/week for 15 weeks or choose a faster/slower schedule
Dedicated course leader who’ll check your progress at the end of every week and follow up with you to help you finish the course
Join 1590 Learners

Male biotechnologist testing new chemical substances in a lab

Image: PVCC

Apply NOW & Retrain for a QA or QC Role in the Pharma Industry

Try Us Risk FREE for 7 Days 100% Money Back Guarantee.

Quality, Pharmacy or Food Science Background? Retrain ONLINE for Quality Control or Quality Assurance Roles in Pharma Manufacturing in 15-Weeks

The Fundamentals of Pharmaceutical Manufacturing Technologies Course GetReskilled

Estimated salaries €39,000 – €80,000 plus overtime, bonuses and allowances. (Based on Irish job data)

Estimated salaries $39,000 – $95,000 plus overtime, bonuses and allowances. (Based on US job data)

Get from your current industry to working in a quality assurance or quality control role in the Pharma and Medical Device industry as fast as possible.
Start your path to a well-paid and rewarding career in pharma manufacturing
Learn how safe medicines are made using GMPs
Application Deadline: Wednesday 25th May

Study Online part-time – complete 2 modules
12 hrs/week for 15 weeks or choose a faster/slower schedule
Dedicated course leader who’ll check your progress at the end of every week and follow up with you to help you finish the course
Join 1590 Learners

See Course Price

Apply NOW & Retrain for a QA or QC Role in the Pharma Industry

Try Us Risk FREE for 7 Days 100% Money Back Guarantee.

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.

Certificate in Pharmaceutical and Medicinal Product Manufacturing

Our learners work for the world’s biggest pharma and medical device companies

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.

View Full 15 Week Syllabus

See Course Price

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.

Week 1 – Manufacturing Safe Medicines

1-1 Finished Medicinal Products
In this lesson, we learn about medical products and the various ways drug products are administered.
1-2 Introduction to Quality Risk Management (QRM)
In this lesson, we will develop an understanding of the history and the crucial importance of risk management as well as the basic steps involved in its application.
1-3 Fault Tree Analysis (FTA) – step 4 “Workshop’ exercise
In this lesson, we learn about the risk management tool ‘Fault Tree Analysis’ and see an example of where and how we can use it.
1-4 Clinical Trials
In this lesson, we will gain an understanding of the purpose of clinical trials and learn about their four phases.
1-5 Focus on Patient Safety and Product Quality
In this class, we will develop a deeper understanding of the importance of patient safety and product quality for medicines and medical devices.
1-6 Process Validation
In this lesson, we will learn about the various definitions of ‘validation’, as well as for ‘commissioning’, ‘qualification’, and ‘verification.

Deliverables

Complete a workshop on Fault Tree Analysis (FTA).
Complete a question booklet that will summarise what you have learnt for the week and help ensure you retain and understand the information.

Week 2 – GMP’s and Quality Management Systems

2-1 ISPE Baseline Guide 5 – Commissioning Practices
In this lesson, we learn about the commissioning and qualification of manufacturing equipment systems in the pharmaceutical industries and about the importance of doing system impact and component impact assessments.
2-2 ISPE Baseline Guide 5 – Qualification Practices
In this lesson, we look again at system and component impact assessment and specifically describe the qualification practices associated with direct impact systems that directly impact on product quality and patient safety.
2-3 ISPE Baseline Guide 5 – Enhanced Design Review (EDR) / (DQ)
In this lesson, we learn how to do a documented review of the design of the overall process and facility systems for conformance to operational and regulatory expectations.
2-4 Cause and Effect – step 4 ‘Workshop’ exercise
In this lesson, we learn about the risk management tool ‘Cause and Effect’ and see an example of where and
how we can use it.
2-5: ISO 9001:2008
This lesson is about the key requirements of quality management systems.
2-6: Good Engineering Practices (GEP)
In this presentation, we will develop an understanding of good engineering practices, and learn about some various organizations that produce them.
2-7: ASTM E 2500 – Standard Guide for Specification, Design and Verification
In this lesson, we will describe a specification, design, and verification approach for equipment systems associated with the pharmaceutical, biopharmaceutical and medical device industries.

Deliverables

Complete a Cause and Effect (Fishbone Diagram) workshop.
Complete a question booklet that will summarise what you have learnt for the week and help ensure you retain and understand the information.

Week 3 – Good Automated Manufacturing Practices (GAMP)

3-1: GAMP5 – Software Category
This lesson, looks at the various GAMP categories of software and a ‘v-model’ approach to software projects? It also recommends a method on how to describe a critical computerized system to the regulatory authorities.
3-2: GAMP5 – Scalable Validation Deliverables
In this lesson, the general content of a computerized validation plan and a summary report is described. Described also is the ‘system implementation lifecycle’ (SILC) and the ‘software development lifecycle’ (SDLC) with associated validation deliverables.
3-3: GAMP5 – Operation Activities
This lesson describes the typical procedural activities associated with all commercial computerized systems in the operational stage of the lifecycle
3-4: Failure Mode, Effects (and Criticality) Analysis (FMEA / FMEAC) – step 4 ‘Workshop’ exercise
This presentation shows an example of the main steps in performing a ‘Failure Mode, Effects Analysis’ (FMEA) and describes how this risk management technique summarizes the important modes of (a) failure, (b) factors causing these failures, and (c) the likely effects of these failures.
3-5: GAMP5 – Risk-Based Decision Making
This lesson explains how to apply risk-based decisions, making over the lifecycle of a computerized system: from the concept phase and through the project phase, into the operational phase and finally to the decommissioning stage.
3-5: Product Quality and Current Good Manufacturing Practices [ cGMP]
In this lesson, we learn how to scientifically define product quality. This lesson also gives an insight into the high-level principles of current good manufacturing practices (cGMP).

Deliverables

Complete a workshop on Failure Mode Effect Analysis (FMEA).
Complete a question booklet that will summarise what you have learnt for the week and help ensure you retain and understand the information.

Week 4 – API Manufacturing Technologies

4-1: Chemical Reactions
In this lesson, we describe chemical reactions and list the substances involved, and explain what the rate-controlling steps are.
4-2: Separation Technologies
In this lesson, we explain how to purify a dissolved compound from a mixture of substances using ‘liquid-liquid extraction’, ‘phase separations’ and ‘crystallization’.
4-3: Batch Organic Chemical Synthesis
In this lesson, we describe the typical equipment and process stages of the manufacture of active pharmaceutical ingredients (API) using batch organic chemistry synthesis.
4-4: Preliminary Hazard Analysis (PHA) – step 4 ‘Workshop’ exercise
This lesson, explains when and how to do a Preliminary Hazard Analysis (PHA) study on a project to analyze hazards, and suggests how to document the process and who should conduct the study.
4-5: Multi-Stage Sequence API Synthesis
In this lesson, we explore the typical sequence of deriving an API product using batch organic chemical synthesis and the types of facilities used
4-6: API Regulatory Guidelines
In this lesson, we describe the characteristics of a GMP that can be followed to manufacture an API.
4-7: Relationship Between BPC and API
In this lesson, we describe the similarities and differences between the terms ‘Active Pharmaceutical Ingredients’ (API) and ‘Bulk Pharmaceutical Chemicals’ (BPC), and we mention some typical material controls?

Deliverables

Complete a workshop on Preliminary Hazard Analysis (PHA).
Complete a question booklet that will summarise what you have learnt for the week and help ensure you retain and understand the information.

Week 5 – Biopharmaceutical Manufacturing Technologies

5-1: Biopharmaceuticals Manufacturing, Upstream, Fermentation
This lesson describes a conventional biotechnological process and introduces the following process sequences:
- Stage-I – Upstream Processing
- Stage-II – Fermentation / Bio-reaction
- Stage-III – Downstream Processing
5-2: Cellular Protein Synthesis
This lesson explains the sequence of how a protein is created at a cellular level in terms of its contents and folded structure, and explains the template information necessary for its assembly process.
5-3: Hazard Operability Analysis (HAZOP) – step 4 ‘Workshop’ exercise
In this lesson, we will watch a practical application of HAZOP that will identify process risk events that are caused by deviations from a system’s design or operating intentions. It is a systematic brainstorming technique for identifying hazards using so-called “guide-words” (e.g., No, More, Other Than, Part of, etc.) and applying them to relevant parameters (e.g., contamination, temperature) to help identify potential deviations from normal use or design intentions.
5-4: Downstream Processing – Column Chromatography
This lesson describes the basic principle behind the following column chromatography techniques:
- Size Exclusion Chromatography (SEC).
- ‘Ionic Exchange Chromatography (IEX).
- Hydrophobic Interaction Chromatography (HIC).
- ‘Affinity Chromatography
5-5: Biopharmaceuticals Manufacturing: Special Considerations
This lesson looks at general considerations for a conventional biopharmaceutical process in terms of cell line preservation and viral barrier and viral clearance techniques.

Deliverables

Complete a workshop on Hazard Operability Analysis (HAZOP).
Complete a question booklet that will summarise what you have learnt for the week and help ensure you retain and understand the information.

Week 6 – Cleaning Validation

6-1: Engineering Aspects of Cleaning, and Cleaning Equipment
This lesson discusses how to clean and decontaminate surfaces using CIP (clean-in-place), agitated Immersion, static Immersion (Soaking), automated parts washers, ultrasonic cleaning, high-pressure spraying, and manual cleaning.
6-2: Chemistry Aspects of Cleaning
This lesson explores chemistry aspects of cleaning in terms of solubility, solubilisation, emulsification, dispersion, wetting, hydrolysis, oxidation and physical removal.
6-3: Event Tree Analysis (ETA) – step 4 ‘Workshop’ exercise
This lesson explores the application of Event tree analysis (ETA). Event tree analysis is an analysis technique for identifying and evaluating the sequence of events in a potential accident scenario following the occurrence of an initiating event. ETA utilizes a visual logic tree structure known as an event tree. The objective of ETA is to determine whether the initiating event will develop into a serious mishap or if the event is sufficiently controlled by the safety systems and procedures implemented in the system design.
6-4: Cleaning Validation
This lesson takes a high-level look at a typical cleaning validation sequence. It looks at how to determine the basis for quantification limits and explains how to determine cleanliness levels on the basis of the analytical testing of representative samples. Sampling is described in terms of sampling-equipment, sampling -locations, and sampling –procedures.
6-5: ISO-9001 ‘Continual Improvement’ & ICH Q10 Pharmaceutical Quality System
This lesson explains the concept of ‘continual improvement’ as part of a company’s quality management system and describes an effective corrective action process and a preventive action process (CAPA). It also gives details on the product-lifecycle for a pharmaceutical product and describes the monitoring of process performance and product quality.

Deliverables

Complete a workshop on Event Tree Analysis (ETA).
Complete a question booklet that will summarise what you have learnt for the week and help ensure you retain and understand the information.

Week 7 – Medical Devices and Sterile Manufacturing

7-1: Tablet Manufacturing
In this lesson, we will explore the critical process parameters and quality attributes associated with the manufacture of medicinal tablets.
7-2: Vial Filling & Freeze Drying
In this lesson, we will explore the critical process parameters and quality attributes associated with the filling of a medicinal vial and its subsequent freeze-drying.
7-3: FDA Medical Device Rules – CFR 820
In this lesson, we look at how the FDA classifies medical devices and explore the basis of that classification system.
7-4: Hazard Analysis and Critical Control Points (HACCP) – step 4 ‘Workshop’ exercise
In this lesson, we are going to look at a full risk management process called Hazard Analysis and Critical
Control Points (HACCP) and develop an understanding of the seven steps involved.
7-5: Medical Devices – EU Classification
In this lesson, we look at how medical devices are classified in the European Union, and we explore the basis of the classification system.
7-6: Aseptic & Sterile Manufacturing
In this lesson, we look at critical process parameters and quality attributes associated with aseptic processing and terminal sterilization products for parenteral products.
7-7: Medical Device Regulations and Guidelines – ISO 13485 / CFR 820
In this lesson, we look at some GMP regulatory and ISO guidance documents that are associated with the manufacture of medical devices.

Deliverables

Complete a workshop on Hazard Analysis and Critical Control Points (HACCP).
Complete a question booklet that will summarise what you have learnt for the week and help ensure you retain and understand the information.

Week 8 – PQ OQ IQ

8-1: PQ, OQ and IQ
In this lesson, we are going to define the terms installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ), and we will also list what typical project design documents are required to prepare such testing protocols.
8-2: Documenting the Quality Risk Management Process
In this lesson, we take a practical look at managing a complete risk management process in terms of identifying risk, analyzing risk, evaluating risk and controlling risk.
8-3: Product Realization & Pharmaceutical Development
In this lesson, we define the pharmaceutical product lifecycle in terms of development, technology transfer, commercial manufacturing and discontinuation.

Deliverables

Complete a question booklet that will summarise what you have learnt for the week and help ensure you retain and understand the information.

Complete an End of Module Assignment

Write a paper on “Why cGMPs are required for the manufacture of a life sciences product”.

Certified by GetReskilled

You will receive an end of course certificate from GetReskilled subject to the following criteria;

Passing a written or oral exam on the materials.
The submission of all assessments and the end of module assignment.

This Certificate along with 2 other modules can be combined into a Certificate in eBioPharmaChem which is university accredited by Technological University Dublin, Ireland.

Module 2 – Advanced Career Coaching (Weeks 11-15)

Week 11 – Learn about the BioPharma/MedTech Industry and figure out jobs you can do

Learn about your local BioPharma/MedTech manufacturing industry in detail
Understanding pharma industry jargon.
How to find the roles that are right for you

Week 12 – Practice skills assessments, write, rewrite and customize CVs and resumes

How to job hunt when you already have a job
Assessing your own skill set and how to sell that to employers
What employers expect from your application
CV and cover letter writing skills that are highly tailored to a job advert with personalized feedback

Week 13 – Speculative job applications and how to research jobs available

Develop a list of appropriate companies and people for speculative job applications
Practice writing speculative applications
How to make successful speculative applications

Week 14 – Social Media, networking and interview preparation

Network effectively both on and offline
How to use social media in your job hunt
Interview preparation
How to deal with psychometric testing

Week 15 – End of Module assignment

Complete a 9-step application process simulation for a BioPharma/MedTech job, using the relevant tools and techniques you have learned, including the following;

Discuss your local BioPharma/MedTech manufacturing industry
List the departments and job roles where your skills are best suited
Understand your current skill set and how to discuss that with employers
Network effectively both on and offline
Write a CV and a cover letter that are highly tailored to a job advert
Write a speculative application and have a list of local companies appropriate for such an application
Prepare for an interview

Certified by GetReskilled

You will receive an end of course certificate from GetReskilled upon the succesful completion of all assessments and assignments.

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.

See Course Price

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.

Fundamentals of Pharmaceutical Manufacturing Technologies Course Certificate

See Course Price

11 Frequently Asked Questions

Is this course delivered online?

Yes, this program is delivered fully online so you can learn from home (or anywhere). Study after the kids have gone to bed.

Is this program university accredited?

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.

What does a typical week look like?

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.

How do you keep track of my progress on the course?

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.