Higher Diploma in Quality Systems Validation with Data Analytics for the BioPharmaChem industry (Higher Diploma in Quality Systems Validation with Data Analytics for the BioPharmaChem industry)

Cork Institute of Technology (Quality Systems)
Key Programme Details

Higher Diploma

NFQ Level

Level 8 About NFQ

Delivery Method



Full Time

ECTS Credits



Physical Sciences @ CIT (physicalsciences.cit.ie, @CIT_PhysSci)

General Information

Dr Ambrose Furey, Senior Lecturer




0214335875 (Mobile 0879116110: Text me and I will


Cork Institute of Technology
Office B245L
Department of Physical Sciences
Rossa Ave.,

(Mobile 0879116110: Text me with enquiries and I will give you a call back)


Course owner

Important Dates
Application Deadline


Start Date


End Date


About this Course

Are you currently working or wish to move to a role in production, processing or test and qualification within regulated industry sectors such as FOOD & BEVERAGE, BIOPHARMACHEM OR MEDTECH?

Are you interested in progressing your career in high skills demand areas such as QUALITY CONTROL/ASSURANCE, QUALITY/COMPUTER SYSTEMS AND VALIDATION (QSV/CSV)?

Do you need to upskill and obtain a qualification in QUALITY/COMPUTER SYSTEMS & VALIDATION in order to progress your career to more senior roles within your industry sector?

Then why not consider CIT's upskilling programme recently funded through the Human Capital Initiative: HIGHER DIPLOMA IN QUALITY SYSTEMS VALIDATION WITH DATA ANALYTICS FOR THE BIOPHARMACHEM INDUSTRY


Candidates wishing to progress or move into roles involving Quality/Validation that have a Level 8 qualification in ANY discipline are strongly encouraged to apply for this course. The course is specifically designed as a "conversion" programme to enable those without a background in science, engineering or related areas but may find themselves working in a regulated environment (or wish to move into such areas) to obtain a qualification in Quality/Computer Systems & Validation (QSV/CSV).

The programme is also highly suitable for candidates who may have a Science, Engineering or related qualification but have no qualification or training in QSV/CSV and wish to pursue opportunities in this area.

The programme places a strong emphasis on professional development, management and leadership skills, all of which will allow students to develop their career aspirations.

This programme is offered by the Department of Physical Sciences at CIT (physicalsciences.cit.ie), which has long-standing extensive experience in delivering industry-specific courses in the area of Quality Assurance and Validation (approved by Excellence Ireland Quality Association). Our lecturing and technical staff have extensive industry experience and continuously engage closely with the region's leading advanced manufacturing sectors.

The course will offer candidates the opportunity to learn about the latest in quality systems and validation principles as well as providing training in the use of the most widely used industry-relevant data analytics and process control software and hardware, in areas such as process control and automation and chromatography diagnostics (further details of specialist training facilities: https://physicalsciences.cit.ie/facilities)

This course includes the opportunity to carry our an industry-based project, either with an existing employer or via a placement. The programme also allows the opportunity to carry out a project with one of CITs associated research groups.

This is currently one of Ireland's only fully-funded level 8 courses in the area of Quality/Computer Systems & Validation for the BioPharmaChem sector.

The HDip course will be delivered via a blended learning approach. Students are expected to be in CIT for up to one evening (Wednesday) and 2 days (Thurs/Friday) per week throughout the first semester (Sept-Dec), these lectures will be delivered online also in most cases. A small amount of practical lab-based work will be carried on-Campus also. For the second semester (Jan-May), students will carry out a project onsite with industry or with one of CIT's associated research centers. Some changes to the proposed delivery format may occur due to the COVID19 situation necessitating remote working and lecture delivery.

If you are interested in applying for this course, please submit the following via the online application system on this Springboard site (direct link: https://springboardcourses.ie/details/8364)

Please note that candidates with a level 7 qualification and extensive relevant industrial experience may also be considered for acceptance on the course via CIT's Recognition of Prior Learning policy and process (https://www.cit.ie/rpl). Candidates will need the following:
(i) Updated CV outlining education and work experience
(iii) A LETTER OF INTENT outlining your interest in the course



*To equip graduates for employment roles in the advanced manufacturing, biopharmachemical, food & beverage, water, petrochemical and medical device sectors.

*To ensure graduates are qualified in the disciplines of Validation, Statistical Quality Control, Data Analytics and Data Integrity.

*To ensure graduates are equipped with all the key skill sets required to support career opportunities in Validation (Computer Systems Validation, Process, Analytical and Clean-room validation), Regulatory Affairs and Data Analytics, with practical applications enhancing the theory to enable learners to develop skills and gain a solid understanding of industrial processes.

*To ensure graduates have the appropriate laboratory-based practical skills training in measurement design and execution, Statistical Quality Control, data analytics, auditing and report writing – all of which are key requirements for job readiness in a regulated manufacturing environment.

*To ensure graduates are competent in computer-based IT skills, the use of software packages for text and data processing (e.g. EMpower, Minitab, SPSS, DeltaV, etc) and in the statistical interpretation of scientific data and industrial processes.

*To ensure graduates have strong communication, management and leadership skills.

Entry Requirements

Open to graduates and experienced personnel with a Level 8 qualification in ANY discipline: natural sciences, applied sciences, business, engineering or related disciplines. Note that this is a conversion course with an emphasis on Quality and Validation principles to be applied across a range of industry sectors. While there is a specific emphasis on the BioPharmaChem sector, a background knowledge in related Science and Engineering disciplines is not essential. Graduates of all areas are encouraged to consider applying given the increasing demand for suitably qualified personnel in sectors such as food and beverage, healthcare, MedTech, etc.


Applicants for CIT's Certificate in Quality Assurance (Level 6) [https://www.cit.ie/course/CRSQUAS6] progamme or the Diploma in Quality Management (Part 1) [https://www.cit.ie/course/CRSQMAN7Y1] programme who also hold a Level 8 qualification may wish to apply to this programme if you already hold a level 8 qualification.

Please note that students may avail of CIT's Recognition of Prior Leaning (RPL) process if they can illustrate through portfolio and certification, that they have completed a previous course and reached the learning outcomes of a particular module in this Level 8 HD.

Long Description

The Higher Diploma in Quality Systems Validation with Data Analytics for the BioPharmaChem Industry is a "conversion" programme newly funded in 2020 under the Human Capital Initiative.

The course is specifically designed through extensive consultation with regionally-based global leaders in highly regulated advanced manufacturing industries to address the skills gaps within the Food, Beverage, Water, MedTech, Smart Healthcare, PetroChemical and (in particular) BioPharmaChem sectors.

The course is designed to draw from a large pool of candidates with an existing level 8 qualification but not specifically related to the science and engineering disciplines - candidates with qualifications from non-STEM areas are strongly encouraged to consider applying if interested in working in these sectors. The programme is primarily structured for candidates who may have found themselves working in such highly regulated environments in roles related to quality/validation but do not necessarily have any formal qualification in this area and are thus limited in their ability to career progress. By completing this HDip programme, candidates will be able to gain a deeper understanding and competency in the area of QSV, which could open up the extensive career opportunities as data analytics, quality control and validation. These emerging roles are becoming increasingly important and in-demand due to the emergence of automation and process control technologies and associated data acquisition/analytics platforms.

Validation, Statistical Quality Control and Data Analytics are areas that have been identified where skilled graduates are needed (see, for example, the report below* by the Expert Group on Future Skills needs) . Companies ensure their processes are accredited, under the criteria laid down by ISO, INAB, ICH along with regulatory bodies (FDA, EMA, HPRA etc). Within these standards, validation is a prerequisite to acquire accreditation. Validation has been recognized as a discipline within industrial quality management systems departments therefore trained staff in this discipline is a necessity.

There has been substantial investment (> €4 billion) recently in the BioPharma Chem sector, enhancing the development of new skills from traditional small-molecule manufacturing. Advances in manufacturing processes from batch to continuous manufacturing is critical to creating the optimum manufacturing environment, utilizing skid technology and prioritizing innovation.

This programme is aimed at those wishing to transition in the latest developments in data analytics and validation, providing a strong talent pipeline for industry, combining knowledge, skills and expertise. There will be a strong data integrity focus, producing graduates with expert knowledge on the methodologies to ensure quality validation and associated data analytics.

The regulatory and validation sections of the course provide an overview of the ISO, INAB, FDA and European regulatory requirements for industry. This includes the requirements of regulatory bodies on validation of software systems used in industry and regulatory requirements on electronic records and signatures, Data Integrity and Quality Risk Management as applied to Computer Systems Validation.


Why Choose This Course

Validation Specialists are an essential part of the pharmaceutical, biopharmaceutical, medical device and biotechnology industries and, as a result, are in increasingly high demand. As advanced manufacturing processes become increasingly automated, the need for Validation Specialists is growing.

The replacement of paper systems with electronic data in the Quality Systems of highly regulated environments, ensures this trend will to continue. Computer System Validation specialists are responsible for validation and testing of computerised systems and ensure quality control. Roles in validation require highly skilled and specialised professionals, salaries are highly competitive.

Likewise, there has been huge growth in the area of Data Analytics in manufacturing industries, especially due to increased data collection of increasingly automated systems. This course has been designed in consultation with the advanced manufactoring sector to address the skills shortage in this area and will equip graduates for roles in systems validation in the manufacturing sector.

Graduates with a level 8 qualification in any area who are currently working in or wish to move into these sectors and need to upskill in Quality Systems and Validation to progress their careers.

This program is suitable for a wide cohort of L8 graduates (NOT NECESSARILY WITH A QUALIFICATION IN THESE SECTORS) and applications will be considered from a diverse range of backgrounds, for example: those working on shift, those made redundant due to COVID 19, those seeking promotion or looking for a career change, those who are currently unemployed, those with a science or engineering degree that wish to upskill, recent graduates, etc..

Career Opportunities

Quality Validation Specialists are in high demand in many sectors of the manufacturing industry as evidenced by recent government reports, in particular the Expert Group Report on Future Skills in the BioPharma sector. This course has been designed to address the skills shortage in this area and will equip graduates for roles in validation in the manufacturing sector (Pharmaceutical, Biopharmaceutical, Food, Beverage, Water & Healthcare sectors).

Timetable Info


The program will involve a blended learning approach, involving a mixture of in class and on-line delivery.

Each 5 credit module will consist of one theory lecture and one tutorial session. The tutorial allocation may involve a computer-based laboratory session where statistical software will be taught and then used to solve relevant problems.

Students are expected to be in CIT for up to one evening (Wednesday) and 2 days (Thurs/Friday) per week throughout the first semester (Sept-Dec), these lectures will be delivered online also in most cases. A small amount of practical lab-based work will be carried on-Campus also.

For the second semester (Jan-May), students will carry out a 30 credit project onsite with industry or with one of CIT's associated research centers. Successful applicants will be encouraged to carry out their project in their place of employment, where applicable, otherwise students will be placed in an associated industry/research centre site for their project duration in Jan-May 2020. Students will liaise with the programme's placement coordinator to identify and secure a placement at their industrial/research site of preference, where possible.

Some changes to the delivery format may occur due to the COVID19 situation necessitating remote working and delivery.

CIT’s Virtual Learning platform CANVAS will be used to manage content delivery for the course. .

Delivery Location

The course will be delivered using a blended approach of lectures and online content. Students are expected to be onsite at CIT's Bishopstown Campus one evening (Wednesday) and two days (Thurs/Friday) per week. However, due to the COVID19 situation it is expected that much of the delivery for Semester 1 (Sep-Dec 2020) will be online on these days.

Please note that students on this programme will graduate from Munster Technological University. On 1st January 2021, Cork Institute of Technology will join with Institute of Technology Tralee to establish Munster Technological University. https://www.mtu.ie/

Delivery Notes


1. Data Analytics and Chemometrics (5 credits)

2. Validation of Systems (5 credits)

3. Quality Management Systems, LIMS & SQC (5 credits)

4. Regulatory Affairs and Auditing (5 credits)

5. Professional Development and Communication (5 credits)

6. Management and Leadership (5 credits)


1. Industry-based Project (30 credits)

Admissions Contact Details
Contact Person



Cork Institute of Technology,

T12 P928

T: 00353 21 432 6100
E: info@cit.ie


021 433 5040



RPL Information

Details of CIT's RPL policy and process can be found here: https://www.cit.ie/rpl. Please contact RPL officer Phil O'Leary (phil.oleary@cit.ie) or Head of Physical Sciences Department Dr. Donagh O'Mahony (donagh.omahony@cit.ie) with any queries.

Application Procedures

Please submit your application via the SPRINGBOARD/HCI online system, please have the following items ready:

(i) Updated CV outlining education and work experience
(iii) A LETTER OF INTENT outlining your interest in the course

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