Pharma Manufacturing Essentials Course – turn your education into a job in pharma

Take this 10-week ONLINE course so you can find a job in the pharmaceutical industry as quickly as possible

You’ll learn all the technical info you need to talk to employers and stand out from your classmates. And we’ll walk you step by step through the job-hunting process for the pharma and medtech industry. 

Why Pharma?

  • Starter salaries from €34,000 – €49,000 per year) depending on your background

  • 73,000 are people directly employed with 8,800 new jobs on the way by 2027

  • Excellent prospects for rapid promotion and a high salary

  • Starting salaries £25,000 – £36,000 depending on your background

  • Strong industry with excellent prospects for a promotion and a high salary

  • More jobs available now than ever before

  • You DON’T need a specific science or engineering qualification to get started

  • Application Deadline: Wednesday 2nd October
  • Study Online part-time 10hrs/week
  • Course is delivered on Moodle
  • Join over 4,000 Learners

NOTE: You’ll get a dedicated course leader who’ll work with you to develop a weekly study schedule, then check your progress every Friday and follow up with you to help you finish the course.

GMP Manufacturing Training | Learn Good Manufacturing Practices

Contact Details For This Course

Geraldine Creaner

Pharma Manufacturing Essentials Course – turn your education into a job in pharma

Take this 10-week ONLINE course and start your career in the pharmaceutical industry

You’ll learn all the technical info you need to talk to employers and we’ll walk you step by step through the job-hunting process. 

GMP training course for the pharmaceutical manufacturing industry

Why Pharma?

  • Starter salaries from €34,000 – €49,000 per year) depending on your background

  • 73,000 are people directly employed with 8,800 new jobs on the way by 2027

  • Excellent prospects for rapid promotion and a high salary

  • Starting salaries £25,000 – £36,000 depending on your background

  • Strong industry with excellent prospects for a promotion and a high salary

  • More jobs available now than ever before

  • You DON’T need a specific science or engineering qualification to get started

  • Application Deadline: Wednesday 2nd October
  • Study Online part-time 10hrs/week
  • Course is delivered on Moodle
  • Join 1120 Learners

NOTE: You’ll get a dedicated course leader who’ll work with you to develop a weekly study schedule, then check your progress every Friday and follow up with you to help you finish the course.

Course Pricing →

Contact Details For This Course

Geraldine Creaner

The world’s biggest pharma and medical device manufacturing companies have hired our graduates after this 10-week program:

Pfizer Logo

AstraZenega Logo

Novartis Logo

GSK Logo

Lilly Logo

Abbott Logo

MSD Logo

Boston Scientific Logo

Medtronic Logo

Takeda Logo

Abbvie Logo

JNJ Logo

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

Pfizer Logo

AstraZenega Logo

Novartis Logo

Lilly Logo

Roche Logo

Amgen Logo

Sanofi Logo

GSK Logo

Stop doing things that don’t work and stand out from your classmates

You’re all going to leave with the same qualification, so how can you stand out from the crowd and set yourself apart?

The answer is simple…

  • Learn to “talk the talk” of the pharma industry so you can confidently answer interview questions and show a genuine understanding of this unique industry
  • Don’t waste limited application opportunities making mistakes – know how to write a CV that really catches attention, learn how to answer different types of interview questions, and figure out how to sell the unique skills you already have

This programme will give you all the technical and job application skills you need to turn your education into an entry level job in pharmaceutical manufacturing. After just 10 weeks (or 10 days in the Fast Track option), you’ll be ready for interviews and confident in what to say to employers.

We deliver the program online through one centralised platform (Moodle). This is where you can log into your classroom, get assignments and interact with faculty. Each week you’ll complete a series of videos, quizzes, interactive activities, and projects through our online platform, available to access 24/7.

You’ll have a dedicated course leader who will email or telephone you if it looks like you’re starting to fall behind.

Please note: There are NO ZOOM classes or webinars!

What You Earn

Earn a Certificate of Award in “Manufacturing Safe Medicines and Medical Devices (GMP)” by successfully completing all written assessments and end of modules assignment.

Add details of your certificate to your CV/Resume or your LinkedIn profile.

GMP training certification

What you’ll learn – There are 2 modules in this 10-week programme

Module 1 – Manufacturing Safe Medicines (6 weeks)

In this module, you’ll learn about the systems used in pharmaceutical manufacturing. You’ll learn about the rules and regulations that need to be followed. And you’ll learn enough technical information to get you talking to employers. You’ll spend 4 weeks learning new technical content and then 2 weeks writing your assignment (but don’t worry, we’ve got a professional writing skills programme to guide you through the assignment writing process and equip you with the written communication skills you need for starting in the industry).

  • Introduction –  to pharmaceutical, (bio)pharmaceutical manufacturing in a GMP (Good Manufacturing Practice) regulated environment, quality systems vs regulation vs validation
  • Industry regulations and guidelines –  including, FDA GMPs for the United States, EMA GMPs for Europen Union, ICH, and PICs GMP regulation
  • FDA medical device rules – medical device regulations & guidelines
  • GMPs vs ISO 9001:2015 – what’s the difference and why we use both
  • Process validation and documentation –  design and verification of manufacturing systems
  • Key manufacturing technologies  – such as organic chemical synthesis, biopharmaceutical manufacturing, tablet manufacturing and aseptic & sterile manufacturing
  • Supporting technologies  – such as purified water generation, storage & distribution, clean steam, water for injection, storage and distribution
  • Introduction to Quality Risk Management (QRM)  – and the importance of risk management and the basic steps involved in its application
  • Professional Writing Skills Program – This will guide you through the assignment writing process and equip you with the written communication skills you need for working in the industry

Module 2 – Advanced Job Hunting Skills (4 weeks)

In this module, you’ll navigate your way, step by step, through the job hunting process for the pharma industry. By the end of it, you’ll know which jobs you’d be perfect for, where to find them, and how to make applications to give yourself the best chance at success.

After you complete this module:

  • You’ll know about your local BioPharma/MedTech manufacturing industry in detail and where the jobs are.
  • You’ll know which jobs you’d be perfect for and where to find them.
  • You’ll be able to assess your own skill set and know how to sell that to employers.
  • You’ll know what employers expect from your application and from a job interview.
  • You’ll be able to follow a step-by-step process to find, apply and successfully interview for your first job in this industry.

You’ll produce a number of deliverables throughout the course including…

  • Complete two workshops on Fault Tree Analysis (FTA) and Failure Mode Effect Analysis (FMEA)
  • Complete four-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 an end of module 4-5 page assignment to include:
    • The key requirements of a quality management system
    • The cleaning validation sequence and how to determine cleanliness levels
    • The documentation of a complete risk management process in terms of identifying risk, analyzing risk, evaluating risk and controlling risk.
    • The typical equipment and process stages used in the manufacture of active pharmaceutical ingredients
    • The generation, storage and distribution of pharmacopeia grade Purified Water (PUW).
    • The common cleanroom configuration and airflow direction that governs personnel and material flows in a biopharmaceutical manufacturing environment

And take the following skills and knowledge to your new job…

  • You’ll have a foundation in how safe medicines and medical devices are made in a regulated GMP environment.
  • You’ll be able to participate in root cause analysis projects.
  • You’ll have enough technical knowledge and understanding of the quality culture necessary to work in this environment.
  • You’ll have the written communications skills to properly write reports and reference and cite source material in a manner that is consistent with the professional norms of this industry.
  • 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.

Your 10-Week Class Schedule

Your Class Director will check your study logs and only will release subsequent week’s materials to you if you have been logging in for more than 10 hours per week.

And he or she will proactively follow up with you to keep you on track.

Module 1 – Manufacturing Safe Medicines and Medical Devices (GMP) (Weeks 1-6)

Session 1 – Industry Regulations & Guidelines for Good Manufacturing Practices (GMP’s) – Part 1

  • Topic-1 Finished Medicinal Products
    In this lesson, we learn about medical products and the various ways drug products are administered.
  • Topic-2 Focus on Patient Safety and Product Quality
    In this lesson, we will develop a deeper understanding of the importance of patient safety and product quality for medicines and medical devices.
  • Topic-3 ISO9001:2008 and ISO 9001:2015
    This lesson is about the key requirements of a quality management system.
  • Topic-4 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) including,

Session 2 – Industry Regulations & Guidelines for Good Manufacturing Practices (GMP’s) – Part 2

  • Topic-5 API Regulatory Guidelines
    In this lesson, we describe the characteristics of a GMP that can be followed to manufacture an API.
  • Topic-6 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.
  • Topic-7 Quality Systems Approach to Pharmaceutical cGMP Regulations-The Quality Systems Mode
    In this lesson, we describe a quality system model in accordance with management responsibilities, resources, manufacturing operations, and evaluation activities.
  • Topic-8 FDA Medical Device Rules-CFR820
    In this lesson, we look at how the FDA classifies medical devices and explore the basis of that classification system.
  • Topic-9 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 question booklet that will summarise what you have learnt for the week and help ensure you retain and understand the information.

Session 3 – Process & Cleaning Validation and Documentation

  • Topic-1 Process Validation
    In this lesson, we will learn about the various definitions of ‘validation’, as well as for ‘commissioning’, ‘qualification’ and ‘verification.
  • Topic-2 ASTME2500 – 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.
  • Topic-3 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.
  • Topic-4 Cleaning Validation
    This class 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.

Session 4 – Risk Management Tools for Scientific Based Decisions

  • Topic-1 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.
  • Topic-2 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.
  • Topic-3 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.
  • Topic-4 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.

Deliverables

  • Complete two workshops on Fault Tree Analysis (FTA) and 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.

Session 5 – Chemical and Biopharmaceutical Manufacturing

  • Topic-1 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
  • Topic-2 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

Session 6 – Tablet, Aseptic and Sterile Manufacturing

  • Topic-3 Tablet Manufacturing
    In this lesson, we will explore the critical process parameters and quality attributes associated with the manufacture of medicinal tablets.
  • Topic-4 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.

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

Session 7 – Purified Water, Clean Steam & Cleaning

  • Topic-1 Purified Water (PUW) Generation, Storage and Distribution
    In these presentations, we look at methodologies to generate, store and distribute pharmacopeia grade purified water (PUW).
  • Topic-2 Clean Steam Generators
    The objective of this lesson is to demonstrate how we produce clean steam using ‘Single-Effect Distillation’ ‘Multiple-Effect Distillation
  • Topic-3 WFI Storage and Distribution
    In this lesson, we take a look at a process for the storage and distribution of pharmacopeia grade water for injection (WFI) and how to maintain its specification
  • Topic-4 Engineering Aspects of Cleaning, and Cleaning Equipment
    This class discusses how to clean and decontaminate surfaces using CIP (clean-in-place), agitated Immersion, static Immersion (Soaking), and automated parts washers, ultrasonic cleaning, high-pressure spraying, and manual cleaning
  • Topic-5 Chemistry Aspects of Cleaning
    This lesson explores chemistry aspects of cleaning in terms of solubility, solubilisation, emulsification, dispersion, wetting, hydrolysis, oxidation and physical removal.
  • Topic-6 Steam Sterilization in Place
    In this lesson, we look at the mechanism behind sterilization of process equipment using saturated steam.

Session 8 – Cleanrooms

  • Topic-1 HVAC Requirements for Non-Sterile API Manufacturing
    In this lesson, we look at how to use airflow direction as a means of a containment barrier between
    operational areas in a non-sterile multi-product active pharmaceutical ingredient (API) manufacturing facility.
  • Topic-2 Cleanroom Layout
    In these presentations, we take a high-level look at a common cleanroom configuration and discuss items such as airflow direction, filter arrangements, cleanroom garments, and personnel and material flows. Another objective of this lesson is to also gain an understanding of personnel and material flows in a controlled airflow environment designed to contain high potency chemicals.
  • Topic-3 Area Classification Protection
    In this lesson, we observe a range of airlock configurations typically used in combination with safety under operational conditions to maintain the specification of critical environmental zones, such as those used in open processing, that have a major impact on product quality and patient.
  • Topic-4 Cleanroom Gowning
    In this lesson, we describe clothing that will minimize dispersion from skin and clothing for personnel working within a cleanroom environment
  • Topic-5 Cleanroom Monitoring – Physical Tests
    In this lesson, we discuss typical physical tests to monitor cleanroom environments: non-viable particle counts, pressure differentials, airflow velocity, air change rate, and filter integrity testing.
Deliverables – Complete a question booklet that will summarise what you have learnt for the week and help ensure you retain and understand the information.

Write a 4-5 page essay, which you could present at a job interview to clearly demonstrate your Technical Knowledge and Understanding of the Quality Culture necessary to work in a GMP regulated manufacturing environment. It will confirm your understanding of how to Manufacture Safe Medicines and Medical Devices in a GMP regulated environment and will include the following topics:

  • The key requirements of a quality management system
  • The manufacturing responsibilities for quality systems
  • The cleaning validation sequence and how to determine cleanliness levels
  • The documentation of a complete risk management process in terms of identifying risk, analyzing risk, evaluating risk and controlling risk.
  • The typical equipment and process stages used in the manufacture of active pharmaceutical ingredients
  • The critical process parameters and quality attributes associated with the manufacture of tablets.
  • The generation, storage and distribution of pharmacopeia grade Purified Water (PUW).
  • The common cleanroom configuration and airflow direction that governs personnel and material flows in a biopharmaceutical manufacturing environment

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.

Module 2 – Advanced Career Coaching (Weeks 7-10)

  • Learn about your local BioPharma/MedTech manufacturing industry in detail
  • Understanding pharma industry jargon.
  • How to find the roles that are right for you
  • 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
  • Develop a list of appropriate companies and people for speculative job applications
  • Practice writing speculative applications
  • How to make successful speculative applications
  • Network effectively both on and offline
  • How to use social media in your job hunt
  • Interview preparation
  • How to deal with psychometric testing

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

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.

Meet Your Online Classroom Support Team

We have a team of in-house experts to provide guidance and support, whenever you need it.

Career Coaching

Safe Medicine Course Director

Meet Claire who runs GetReskilled’s Advanced Career Coaching Programme – our specially devised job hunting course that helps our trainees take that final step into employment by leading them through the job hunting process.

Course Leaders, Coordinators and Classroom Support

Safe Medicine Course Coordinators

Your Course Leaders & Coordinators are here to provide you with answers, tips, and are going to check your progress weekly to keep you on track and will reach out to you by email or even by phone if you fall behind!

Price & Start Dates

Price & Start Dates