This is the first blog in a new ‘Career Insights’ series and we talk to Antonella Troysi, seQure Senior GxP QA Consultant, to find out more on her job, career path, achievements, and her hobbies.
Can you give us an insight into your work in seQure?
As QA consultant, I work directly with our clients. They are mostly pharmaceutical and small biotech companies, CROs, or Phase I Units.
My work is divided in 4 blocks:
- GCP activities, such as revision and writing of SOPs for our clients
- Acting as internal QA for our clients – usually Phase I Units and CROs are interested in this type of support
- Conducting audits on behalf of our clients – for example, auditing a clinical site, a Trial Master File, or conducting a vendor qualification
- Acting as auditor of Phase I Units according to AIFA decree 809/2015
What does your day typically look like?
There is no such thing as typical day for me! I do plan for a week or a month, and my schedule is wrapped around the client requests. I need to distribute my time between sponsors, CROs, small biotechs, and Phase I Units.
My work requires a lot of travelling because of audits. Of course, some tasks I can do remotely, but I work also with documents that exist only in paper form.
Can you tell us about your background?
Pharmaceutical Chemistry and Technologies, I studied in University of Pisa. During the University I got passionate about pharmacology, so while finishing my 5-years degree I enrolled the 4-year postgraduate specialisation course. I was also working as a pharmacist during it! But I didn’t stop there, in fact I also got a Clinical Research Associate Master’s degree afterwards.
What was your journey to your current position in seQure?
I worked for 13 years in a biotechnology company, where I had an opportunity to follow all the stages of a clinical trial. QA became my passion, so I have decided to focus on it. I started to look for QA consultancy opportunities, and now I am part of seQure team!
What career achievement you are most proud of?
My job often pushes me outside my comfort zone and as a result I have to undertake a new challenging audit or learn and absorb new skills quickly. I find this incredibly satisfying and it is a good way to grow!
Nothing compares to achieving a new goal with hard work and determination.
What do you like the most about working in QA?
I love teaming up with our clients to bring quality in everyday activities and processes. Team is an important word here – only collaboration brings real change and seeing the results of these joint efforts is really inspiring.
What would be your top tips for early career specialists looking to develop in QA?
- Be detail-oriented! As a QA professional, you need a sharp eye for detail.
- Stay updated on the QA-related legislation. The regulatory world is in continuous evolvement, especially now when the technology came into play.
- Last, but not the least – be passionate about what you do! The final aim of an audit is ensuring clinical trials are conducted safely and are producing accurate and reliable data. There is a significant amount of human interaction and it is important that you are engaging, curious and ready to collaborate.
What are your personal values?
I value honesty! I strongly believe that being respectful and mindful of other people is the basis when developing good relationships and building a collaborative working environment.
What do you love to do for fun?
I have loads of hobbies, I am keen on trying new things. However, if I have to choose two main hobbies, I would go with reading and travelling. I spend a lot of time in bookshops and exploring new countries, like Peru or South Africa.
About Antonella Troysi
Senior GXP QA Consultant at seQure
After a Master’s degree in Chemistry and Pharmaceutical Technologies, Antonella began her professional career as a hospital pharmacist (UF Farmaceutica Territoriale Zona Val di Cornia, Piombino, Livorno). In 2003 she joined a large biotechnology company as Clinical Research Associate and then took on the role of Drug Safety & Clinical Quality Assurance Officer in 2006. She joined seQure in 2016 as Senior GxP QA Consultant.
Antonella is an expert in the field of quality assurance systems and GCP regulatory compliance and GCP audits. Over the years, she has had several experiences of regulatory inspections conducted and / or coordinated by regulatory authorities such as EMA, FDA, AIFA. She is an active member of the Italian Quality Assurance Research Group (GIQAR).
Do you want to become part of seQure team? We are a dynamic company and constantly looking for new talent to join our team. Check our current job openings and apply!