What is your role at eyetec?
I am a Quality Assurance specialist and work as a registered Qualified Person (QP). I take on interim assignments where I support companies and provide consultancy on how to improve quality systems. As a QP, I’m responsible for assuring the quality of medicinal products. By law, a QP needs to guarantee that medicinal and ATMP products meet the required quality standards and legislation to be administered to patients. I’m qualified to deliver the certification that allows drugs to be released on the market. QP’s have a big responsibility and are civilly liable.
What did you study?
I studied Pharmacy at the KU Leuven, followed by an Advanced Master’s degree Industrial Pharmacy in an Interuniversity programme. I’ve always been interested in science, so after high school, I wanted to pursue an education in that field. I considered biology, bio-engineering, and pharmacy as viable options. At the time, there was a shortage of pharmacists, which prompted me to head in that direction.
How did you start your career in QA/QP?
I began my career at Janssen, where I worked for 8 years. I started out as a team leader in charge of a group of operators who produced sterile drugs. Given the highly regulated environment, we had to adhere to aseptic techniques and used several high technologic solutions to maintain the sterility of the product. After this, I became responsible for the validation of aseptic processes and sterilisation processes for the Janssen Beerse site. This meant running tests to validate these processes and equipment and ensure their sterility. I also presented these processes during regulatory inspections (FDA, FAGG, Anvisa,...) . and was responsible for the documentation that attested that site was equipped to produce sterile drugs. My third role was as a tech transfer project manager of sterile products. I had to make sure that medicinal product production processes could be upscaled from research scale to commercial plants.
eyetec has a lot of ATMP experience. Did you have specific ATMP training?
I did have basic biotechnology during my university degree. However, this wasn’t specifically focused on ATMP. I gained most of my knowledge on the job. Besides this I did extensive self-study and followed webinars and courses at home and abroad.
What is your main area of expertise?
GMP (Good manufacturing practices) regulations regarding aseptic processing and ATMPs. This means that I focus mainly on the quality system and the regulatory framework surrounding the production of sterile drugs and ATMPs. While researchers develop medical innovations, QPs make sure these innovations are safe enough to be administered to patients.
What does a typical workday of a QA/QP in sterile manufacturing look like?
Quality is a diverse topic that involves many different aspects. So every day is completely different. Some recurring tasks include internal audits, managing production deviations, qualifying aseptic processes, qualifying suppliers, releasing products, …
What project are you currently working on?
Two days a week, I’m working as a registered QP at UZ Ghent. As QP I build controls into the production process to ensure the quality of ATMPs. Professor Vandekerckhove MD PhD and his team are researching immune and gene therapy for cancer treatment, which enables the body’s own immune cells to attack cancer cells. The process relies heavily on biological material, so every step of the process is subject to strict quality regulations stipulated by EU GMP legislation.
My role within the project is to monitor and inspect the process and ensure that everything runs according to the regulations. I need to guarantee the quality of the material and the process so that the final products are delivered according to expectations. In addition, I also test samples on critical aspects such as sterility, assay, purity, ... Each product has its own set of parameters; depending on the collected data, we decide if a specific product meets the quality requirements and standards. When someone takes over full-time at UZ Gent, I will remain involved on a consultancy basis and as a back-up.
will remain involved on a consultancy basis and as a back-up.
What is your favourite aspect of the job?
The variety, which is also the main reason I started working at eyetec. Because of eyetec’s vast network, I’m able to work in different industries, with different people and on different products. I also appreciate the amount of expertise I’ve acquired at eyetec. Bram - co-founder at eyetec - is very knowledgeable and shares experiences from previous assignments and customers.
What do you like most about eyetec as a company?
There’s a great atmosphere among colleagues, and the managers are very approachable. They really invest in team spirit and organise fun activities during and after hours, which really enhances the ambience.
What are your favourite afterwork activities?
I love being a father and taking care of my children. I used to do triathlons before, but now I stick to recreational running and cycling whenever I can. I’ve always been part of a youth movement so during weekends, I still really enjoy different types of activities with friends.
Are you currently binge-watching any tv shows?
I just finished watching House of the Dragon, and I’m currently hooked on Gomorra. But The Wire remains the best series ever.
find out more about eyetec's QA QP services