• Jan Damm

Structural shortage of Qualification and Validation Engineers in the Life Sciences & Health sector

Bijgewerkt op: 2 sep. 2021

The Life Sciences & Health sector is characterized by complex and demanding legislation and regulations on quality (GxP, collective names for, amongst others, GMP, GDP, GLP and GCP), and is very knowledge-intensive. Compliance is crucial to success, and this is also reflected in the requirements for the workforce. There is a strong need for people who are knowledgeable, have the right compliance mentality and able are to apply GxP laws and regulations correctly.

Qualification and validation is an important subject within GxP legislation and regulations. Qualification and validation means that there is scientific and documented evidence that processes, systems and equipment can produce products consistently and with the right quality. Specialists in this field help organizations with the implementation or take on an important assurance step: the QA review.

There is a growing structural shortage of qualified specialists, resulting in a structural imbalance of supply and demand. Vacancies are filled with great difficulty throughout the Netherlands and abroad. Moreover, it is difficult for SMEs to retain these specialists for a longer period of time.

The shortages for specific functions in Life Sciences & Health sector have been demonstrably problematic for some time. Secondment agencies often indicate that at least half of their highly educated employees are hired from abroad. This is more expensive than hiring Dutch engineers (partly due to costs for housing and the skilled workers migrant scheme).

There is a shortage in the labor market for specific Engineering and Quality positions for several reasons:

  1. An increasing demand for these positions due to the increased complexity of processes and regulations.

  2. The comprehensive knowledge of college and university graduates with technical degrees traditionally does not sufficiently align with the wishes and requirements of Life Sciences & Health companies. Graduates lack the specific knowledge and skills required to work in the highly regulated environment of many Life Sciences & Health companies, such as the pharmaceutical industry. There is also a barrier in recruiting people with professional (technically appropriate) work experience gained outside of the sector.

  3. There is no vocational training available to prepare people for these positions. This is why most positions are fulfilled by employees “from within” the company who have been working there for a number of years. However, this is becoming less of an option due to increasing demand and companies that do not have the time and / or funds to train employees.

  4. Over the years, many of the current specialists in the field have grown alongside the increasing demands and complexity. However, the gap between training and practice for starters has widened.

The structural and growing shortage of qualified employees for these positions hinders the growth and quality of the sector and puts a brake on the region's attractiveness as a location for Life Sciences & Health companies and organisations.

The Pharmability project

The Pharmability project is a labor market project aimed at improving the imbalance between supply and demand for people with Qualification and Validation knowledge and skills in the Life Sciences & Health sector, as well as the mobilization of specific knowledge. The goal will be achieved by:

  1. Intensive vocational training. With the Pharmability program, PharmSupport contributes to the (continuous) employability of people in the Life Sciences & Health sector. The aim is to better align the supply and demand of people with qualification and validation knowledge and skills within the Life Sciences & Health sector. A specific step is to organize a post-graduate course in the field of Qualification and Validation. This course is offered in collaboration with the HAN University of Applied Sciences and is intended for people who want to be trained as a Qualification and Validation Engineer or a QA Officer. The training aims to prepare these people for setting up, implementing and / or assessing qualification and validation processes. This requires intensive vocational training. The study load is approximately 300 hours. Participants gain background knowledge of the Life Sciences & Health industry and extensive and in-depth knowledge on laws and regulations of validation and qualification. Additionally, many practical assignments involve practicing the activities at various stages of a qualification and validation process. Finally, attention is given to additional skills that are required for the position, such as project management and soft skills.

  2. The GxP expertise center for the southern region of the Netherlands. SMEs are often made aware of compliance requirements at a late or too late stage, and are thus unprepared. As a result, developments (for example, the final development of a new medical product) are delayed, blocked or the production and sale of an existing product is compromised. With this in mind, the GxP expertise center for the southern region of the Netherlands was established. The expertise center can be characterized as a helpdesk where SMEs can request low-threshold second and third-line support for quality assurance and compliance of GxP systems, processes, facilities and amenities. The center will mainly function as a virtual knowledge hub where organizations and SMEs in the Life Science & Health sector can (digitally) call for advice, consultation and support. The expertise center aims to:

  • Support companies and organizations in an accessible way with any questions about quality assurance and compliance of GxP systems, processes, facilities and amenities. Leading topics will concern commissioning, qualification and validations.

  • Ensure SMEs in the Life Sciences & Health sector are (more) aware of the regulatory obligations of product development with regard to systems that must be GxP compliant, processes, facilities and amenities at an earlier stage.

  • Create a knowledge network and platform for compliance professionals.

More information about the Qualification and Validation Engineer course?

More information about the Qualification and Validation Engineer course? Click here to go the HAN website.

Would you like to contact the GxP expertise center? E-mail expertise@pharmsupport.nl.

The Pharmability program is an initiative made possible by the financial support from the European Regional Development Fund and the province of Noord-Brabant.

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