Portraits from the pharmaceutical wholesale

Interview with Dr Andrea Zsótér, Quality Assurance Director of Hungaropharma Zrt.

How should we imagine the work of a quality assurance director in a prominent player in the pharmaceutical wholesale sector?

A pharmaceutical wholesaler must deliver medicines and other products with impeccable quality, certified origin, in the right quantities and on time to customers – in particular to pharmacies, hospitals, other wholesalers. To do this, the underlying systems it operates - e.g., inventory, logistics - must also be of high quality. Quality assurance is the area responsible for the regulation, supervision and further development of all these activities. It includes the selection and qualification of suppliers, the qualification of incoming medicines, the training of wholesale staff and the operation of the documentation system. This also includes the qualification of the equipment, devices and areas used for storing and transporting medicines, the continuous temperature monitoring of these, and of course our work now also includes monitoring and validation of IT systems, stock control systems. We check the compliance of processes and partners through audits and manage deviations and changes. We also work beyond the processes within the company, for example, we sign quality assurance contracts with suppliers and contracted partners. Closed-chain medicines can only be transferred to a partner who is authorised to do so, and this must also be checked before the contract is concluded.

How did your career lead you to this responsibility?

Already in high school, I became interested in pharmacy. I was a student of mathematics in Szeged, and I loved real subjects, and I was also a member of the chemistry class. Several of my maths teacher's family were pharmacists, and my best friend's mother worked as a pharmacy assistant. I wanted to continue with real subjects, but it was also important to have a job that offered a variety of opportunities and was about helping other people. So, I applied to the University of Szeged and graduated from the Faculty of Pharmacy in 2000 as a pharmacist.

The diversity of what I imagined pharmacy to be like when I was in high school has been amply confirmed throughout my career. I started working in a public pharmacy, although I had originally planned to work in the pharmaceutical industry. This was later granted to me, and I started my career as a laboratory manager in a pharmaceutical company, and later took over part of the supervision of the Inter-Production Control (IPC) laboratories. In my first job in this pharmaceutical company, I was promoted to the position of Warehouse Quality Assurance Team Leader in the Solid Pharmaceuticals Plant. My responsibilities have steadily increased, and I have also been given responsibility for plant-level quality assurance. Subsequently, I worked in various pharmaceutical companies with an international background as Quality Assurance Director, responsible for areas such as pharmaceutical wholesaling, third country imports of pharmaceuticals and investigational medicinal products, clinical trials, aseptic drug manufacturing, among others.

It has been a particular challenge for me to take on the role of Head of Technical and Quality Assurance at HUMVO.  This non-profit organisation was set up to establish and operate the national medicines verification system in Hungary as part of the European medicines identification system. This verification system is one of the foundations of the safety of medicines supply. In this job, I have been in contact with a very large part of the pharmaceutical supply chain in Hungary, i.e. pharmaceutical companies, pharmacies, hospitals, pharmaceutical wholesalers, marketing authorisation holders. I joined Hungaropharma Zrt. from HUMVO in 2020 as Quality Assurance Director.

What gives you motivation every day?

In my current job, I can apply the knowledge I have acquired throughout my career, and I have a very varied job. But here, at a market player of this size, it's not surprising: as a full-line pharmaceutical wholesaler, we handle a wide range of pharmacy products, have a supplier base of hundreds of companies, and operate an extensive logistics system. Our work has also an impact on the supply of medicines in Hungary, on people's health, and it is important for me that this is part of the company culture. The company also values quality work, compliance with rules, efficiency, development and building for the future. I work with excellent colleagues who can rely on each other, whether it's for the day-to-day routine or for the extraordinary challenges.

How do you balance your work and private life?

I have two grown sons, aged 18 and 14, and spending time with my family means a lot to me. In my spare time I also do creative activities, lichen paintings, door knockers, even painting furniture, and anything to do with plants and gardening is a special treat for me. My recreation is also supported by two reformer Pilates sessions a week - I've been going for years and I'm glad I found this opportunity. It's important for me to work in a good team, and it's equally important to create and maintain a healthy work-life balance.