Lab/Science, Biochemistry, Microbiology, Molecular Biology, Background?
Retrain ONLINE for Development, Manufacturing, QA or QC Roles in Pharma Manufacturing in 15-Weeks

Take our “Conversion Course into Pharma for Scientists” to work in the pharmaceutical manufacturing industry.

  • Start your path to a well-paid career in pharma manufacturing

  • Learn how safe medicines are made using GMPs
  • Application Deadline: Wednesday 4th November

  • Study Online 14 hrs/week
  • 2 Modules over 15 Weeks
  • Join 3220 Learners
quality assurance associate
Apply NOW & Retrain for Development, QA, QC or Manufacturing Roles

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

Lab/Science, Biochemistry, Microbiology, Molecular Biology, Background?

Retrain ONLINE for Development, Manufacturing, QA or QC Roles in Pharma Manufacturing in 15-Weeks

Take our “Conversion Course into Pharma for Scientists” to work in the pharmaceutical manufacturing industry.

Conversion Course into Pharma

Why Switch to Pharma?

  • Start your path to a well-paid career in pharma manufacturing.
  • Learn how safe medicines are made using GMPs
  • Application Deadline: Wednesday 4th November

  • Study Online 14 hrs/week
  • 2 Modules over 15 Weeks
  • Join 3220 Learners
Apply NOW & Retrain for Development, QA, QC or Supporting Manufacturing Roles

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

Why Take This Course?

Your skills are a great foundation for a variety of roles across the pharmaceutical manufacturing lifecycle But you need more.

You need to understand the industry regulations, the different regulatory standards (US, European, World Health Organisation, etc), work practices, approaches to risk management, data integrity approaches, and industry protocols that are critical in the manufacture of safe medicines.

And..

  • You want end-of-week progress checks and follow by us to MAKE SURE you finish the course.

  • Delivered Online you can work full time and still study without wasting your time or money commuting or getting stuck in traffic.

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

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Abbott Logo

Novartis Logo

GSK Logo

Lilly Logo

Novartis Logo

MSD Logo

Boston Scientific Logo

Medtronic Logo

Takeda Logo

Abbvie Logo

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

Pfizer Logo

Abbott Logo

Novartis Logo

Lilly Logo

Roche Logo

Amgen Logo

Sanofi Logo

GSK Logo

Minimum Entry Requirements

Any ordinary, honours, masters degree or above in the following:

  • Laboratory Science
  • Biochemistry
  • Biotechnology
  • Food Science
  • Cell Biology
  • Chemistry
  • Immunology
  • Microbiology
  • Any other Biological Science
  • Any other Chemical Science
What is a quality engineer and what do they do?

What Kind of Roles Could I Retrain For?

Development

This 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. There are specific challenges associated with this, and scientists play a key role in successfully scaling up the manufacturing process while maintaining product quality. These are practical roles working in a regulated environment that bridge the gap between pure science and the product in a patient’s hand.

Development roles might be a great fit for you if:

  • You have a BSc in a chemical or biological or similar science
  • You have hands-on lab experience
  • You have an understanding of GMPs (or are willing to take a course to learn them)
  • You want to help bridge the gap between pure science and the product in a patient’s hand

There are a diverse range of development opportunities available throughout the pharmaceutical industry. Specific roles will depend on the product being developed, and the stage of development.

What science specialities are the best fit?

You will see some roles that have a specific chemical or biological speciality required but when we analysed industry job adverts, we found most roles had some flexibility around the specific subject. What appears to be more important is the particular skills you have, and your ability to bring an accredited science mindset to the role.

Where to look for science opportunities in development

Development roles can be in-house with pharmaceutical companies, or as contract roles.

Supporting Manufacturing

Manufacturing is the ongoing production stage of the pharmaceutical industry. This is usually carried out by big teams in large manufacturing facilities. Ongoing product quality is key here and there are strict rules and regulations that need to be followed (including Good Manufacturing Practices – GMPs). Typical roles support the manufacturing process in a regulated environment and work within multidisciplinary teams to produce medicinal products.

Manufacturing roles might be a great fit for you if:

  • You have a BSc in a chemical or biological or similar science
  • You have hands-on lab experience
  • You have an understanding of GMPs (or are willing to take a course to learn them)
  • You want to work in a multi-disciplinary team to produce medicinal products

In most companies, the manufacturing process is carried out by operators and technicians, but scientific staff are required to support these individuals and the manufacturing process. In the case of very specialised products, scientific staff may take a more hands-on role in the routine manufacturing process. Specific roles and opportunities will always depend on the product being manufactured.

What science specialities are the best fit?

You will see some roles that have a specific chemical or biological speciality required but when we analysed industry job adverts, we found most roles had some flexibility around the specific subject. What appears to be more important is the particular skills you have, and your ability to bring an accredited science mindset to the role.

Where to look for science opportunities in manufacturing

Manufacturing roles can be found in-house with pharmaceutical companies or with contract manufacturing companies.

Quality Assurance

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. This is achieved by creating, revising, and strictly implementing a set of precisely defined procedures and quality standards that, when followed exactly, ensure the final quality of the product.

Quality assurance roles might be a great fit for you if:

You have a BSc in a chemical or biological or similar science
You have an understanding of GMPs (or are willing to take a course to learn them)
You are detail orientated, particularly with documentation
You have excellent written communication skills

What science specialities are the best fit?

While a BSc in a chemical or biologica or similar science is necessary, the specific degree is usually irrelevant. What appears to be more important is the particular skills you have, and your ability to bring an accredited science mindset to the role.

Where to look for science opportunities in manufacturing

Quality assurance roles can be found in-house with pharmaceutical companies or via contract roles with engineering consultancies.

Quality Control

Quality control is product-oriented and focuses on testing samples from the manufacturing process to make sure they meet the required specifications and standards. This sample testing is done within in-house laboratories in pharmaceutical companies and all roles within quality control are opportunities for chemistry graduates and chemists or those with hands-on lab experience.

Quality control roles might be a great fit for you if:

You have a BSc in a chemical or biological or similar science
You have hands-on lab experience
You have an understanding of GMPs (or are willing to take a course to learn them)
You want a lab-based role but within a larger manufacturing team environment
Overview of science opportunities in quality control

What science specialities are the best fit?

While a BSc in a chemical or biological science with excellent lab skills is necessary, the specific degree is usually irrelevant. What appears to be more important is the particular skills and lab experience you have, and your ability to bring an accredited science mindset to the role.

Where to look for science opportunities in quality control

Quality control roles can be found in-house with pharmaceutical companies.

By the end of this program, you”ll be able to:

What you’ll learn – There are 2 modules in this 15-week program

Module 1 – Fundamentals in Pharmaceutical Manufacturing (Weeks 1-10)

In this module, you’ll learn the industry regulations, the different regulatory standards (US, European, World Health Organisation, etc), work practices, approaches to risk management, data integrity approaches, and industry protocols that are critical in the manufacture of safe medicines.

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

This is the career bit. In this module, you’ll navigate your way, step by step, through the job hunting process. This specially-designed module is industry-specific. 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.

Hear From People Who’ve Taken This Course
Pharmaceutical Degree

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.”

Pharmaceutical Degree

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.”

Pharmaceutical Degree

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!”

Computer System Validation

Noel O’Brien

“The quality of the course content was excellent and very substantial and covered all aspects associated within the Pharmaceutical, Bio-Pharmaceutical and Medical Device industries. Information that I feel could and would be very much a requirement for the type of work I would be seeking, within such companies.”

Computer System Validation

Ewa K.

“This course would give you chance to continue to seek an employment and at the same time you can study to improve your chances at the job market.”

Computer System Validation

James Fogarty

“This was fantastic opportunity for me to gain qualification in my own time. This would otherwise have been impossible due to cost and time due to child minding.”

Computer System Validation

Trish Kineen

“It has been a great course to re-familiarise myself with the area after such a long time away. I is also brilliant that you can study in your own time & at home (so you don’t have travel & child minding costs). I found the pace of the course good and really enjoyed it.”

Pharmaceutical Degree

Darren Deehan

“I have really enjoyed the course. The course content was very detailed and way surpassed my expectation. While the course was challenging, the online support and access was exceptional. I am really looking forward to progressing to the follow-on/specialization course, “BioValidation” when it becomes available.”

Pharmaceutical Degree

David Masterson

“The courses are detailed, easily accessible, great to add to your CV or to compliment other qualifications.”

Pharmaceutical Degree

Johan Rousseau

“Already told friends, and they are on the course. It is a good course to familiarize you with the Pharma Manufacturing Industry.”

Pharmaceutical Degree

Josephine Nelson

“I would recommend enrolling, the course is very interesting.”

Pharmaceutical Degree

Louise McManus

“Excellent course, well set out.”

Delivered by an Industry Expert

Dr.Joe Brady Lecturer at GetTeskilled

Dr. Joe Brady

Full-Time Validation Lead
Lecturer, Technological University Dublin, Ireland
Senior Associate, GetReskilled

Dr. Joe Brady is 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.

What Does the Online Classroom Look Like?

How does Studying Online Work?

We use one centralized platform where you can log into your classroom. There you can get assignments, interact with faculty and peers, reply to message boards, and more.

Each week, you’ll complete a series of videos, quizzes, interactive activities and projects through our online platform, available to access 24/7.
We release only one week’s worth of material at a time and then MANUALLY 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. And you’ll have a dedicated course leader who will follow up with you if it looks like you’re starting to fall behind.
Your working schedules are unpredictable so we offer flexible delivery. Slow down, speed up or pause the delivery of the course.

Your 15-Week Class Schedule

Your Class Director is going to check your study logs at the end of every week and will only release the following week’s materials to you if you have been regularly logging in and completed the previous week’s activities.

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

Download Brochure

Module 1 – Fundamentals in Pharmaceutical Manufacturing (Weeks 1-10)

  • 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.
  • 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.
  • 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).
  • 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?
  • 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.
  • 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.
  • 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 b