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Five minutes with Iulia Stingu, Senior Compliance Engineer .

29 Nov 2022

Meet Iulia Stingu, one of our specialists in Compliance & Computerised System Validation (CSV), and a member of our Austrian team in Vienna. Experienced in all matters relating to the regulatory requirements on CSV and data integrity, Iulia’s an expert in quality control and assurance for the delivery of biopharmaceutical projects.

Highlights .

  • Lead in qualification and validation phases of projects
  • Managing interdisciplinary C&Q teams
  • Expert in regulatory requirements on CSV and data integrity

What does your role involve?

My work basically ensures that facilities and assets are ready for production. I take the lead in the qualification and validation phases of a project, developing concept options and other supporting work such as risk assessments, Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and validation processes together with my team. I’m responsible for managing interdisciplinary C&Q teams which has more of an emphasis on stakeholder engagement and communication across the project, keeping everything on track and people up to speed.

How did you get into qualification and CSV?

I never really planned to work in this sector, I was always interested in medicine and life sciences and wanted to build a career in a field that helps people and animals. I ended up studying Chemistry, focusing on biochemistry and cancer research and moved onto laboratory work after that.  

Luckily for me, I landed a role in a Quality Systems team in the Quality Assurance department, gaining experience in qualification and validation activities, and also data integrity standards for processes and computer systems. Company audits and inspections keep you on your feet and I love the creativity involved in always finding the best possible solution. That’s what makes us engineers.

What are the challenges of working on compliance/CSV projects in the pharma and life sciences sector?

Due to the nature of the work, this is a highly regulated industry and rightly so. It’s important that engineers keep themselves updated on all the Computerised System Validation (CSV) and Compliance/Data Integrity (C/DI) requirements across the globe; this means that they can develop durable process and facilities strategies for clients, regardless of their location or project complexity.

It can also be our role to find the right supplier who can meet all the necessary project requirements and deliver safe and compliant systems. This means we often need to think outside the box, working creatively with interdisciplinary delivery teams who’ve all inputted into the design across the stages.

What do you enjoy most about the job?

The fact that every project is different, each one seems to feel more interesting than the last and as a result I’m always learning. Sustainability is high on everyone’s agenda currently, so this is the focus for my own development as well as the team’s. I also love to research inspection trends, requirements and all the available technologies in the sector, this ensures we’re always improving both for ourselves and our clients.  

I very much enjoy the training side of what I do – CSV and data integrity can be complicated, particularly for those just starting off their careers so it’s good to help project members and colleagues with their understanding of the topic.

For anyone looking to get into this field, my advice would be to start with working in a GMP laboratory or manufacturing area for hands-on experience with current processes and systems. Modern processes are all steered by computerised systems such as MES, LIMS, warehouse, quality management systems, and with the industry now exploring the digitalisation of manufacturing processes, a broad understanding of IT applications, security, disaster recovery and back-up procedures is paramount.

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