From Junior Consultant to PQS Lead Auditor: A master class in career acceleration
In less than two years, Nathalie Kristine Miró has catapulted her career from her first job out of University of Copenhagen’s School of Pharmaceutical Sciences to recently passing a monster of an exam as GMP PQS Lead Auditor. With NIRAS as her professional backdrop and support system, Nathalie has achieved a rare and impressive goal – becoming PQS Lead Auditor at a young age and with under two year’s professional experience.
Sky is the limit – ring a bell?
If Nathalie’s name strikes a note, it’s because we’ve boasted about her before. In 2023, we wrote about her career trajectory with NIRAS, and it’s safe to say that things have not slowed down for Nathalie since we last talked.
Since joining the QA/RA team in NIRAS Life Science two years ago, Nathalie has worked at Statens Serum Institut as QMS (Quality Management System) responsible, where her contract was extended two times. After that, her manager and mentor asked her if she would be interested in training to become either PQS (Pharmaceutical Quality System) Lead Auditor or maybe QP (Qualified Person).
“I actually had difficulties deciding which way to go when my manager presented me with these two development tracks. It’s always been my goal to have as versatile a profile as possible, so I ended up asking him if one choice excluded the other. Luckily, my manager was open to me possibly doing both, and so we made a tight development plan with a rather steep learning curve. I was made auditor trainee and went with my manager on different audits, absorbing all the knowledge I possibly could.”
“I actually had difficulties deciding which way to go when my manager presented me with these two development tracks. It’s always been my goal to have as versatile a profile as possible, so I ended up asking him if one choice excluded the other.
Luckily, my manager was open to me possibly doing both, and so we made a tight development plan with a rather steep learning curve. I was made auditor trainee and went with my manager on different audits, absorbing all the knowledge I possibly could.”
Training for a marathon
In March 2023, Nathalie started on her second project as QA Specialist with Bavarian Nordic, and in August she moved to Region Hovedstadens Apotek as CCS (Contamination Control Strategy) responsible and expert in sterile drug manufacturing. After having her contract extended five times, Nathalie’s manager decided that it was time that she went to the U.K. to take her shot at the GMP PQS Lead Auditor exam.
Going up against professionals with +5 years worth of experience and independent audits performed, Nathalie was the underdog with 1½ years’ experience at the time and zero independent audits. The exam prep course was just as demanding as her manager had warned her it would be, with 10 hours classroom training every day and self study at night. The exam itself was a written exam defined by a high level of legal content, paragraphs and cases.
“I was actually convinced at one point that I had bit off more than I could chew, because the bar was so high and the curriculum so complex and technical. I really wanted to pass the exam but I wasn’t sure that I would be able to.”
The waiting game
Four weeks later, the answer arrived. In the middle of the photo session for this article actually – so this is exactly what it looked like when Nathalie found out that she could now call herself GMP PQS Lead Auditor:
“It’s unreal, really. Now, I can inspect /audit pharmaceutical companies in EU GMP legislation. And maybe, this is where the QP training track starts…?”.
We’re – just as last time we told Nathalie’s story – excited to follow her development, and happy to be able to help her become the versatile profile that she aims to be.
If you want to know more about what NIRAS works with in the Pharma and Life Science sector, visit us at https://www.niras.com/sectors/pharma-and-life-science/ and make sure to follow us on our LinkedIn for insights and news: https://www.linkedin.com/showcase/niras-life-science/?viewAsMember=true
“It’s unreal, really. Now, I can inspect /audit pharmaceutical companies in EU GMP legislation. And maybe, this is where the QP training track starts…?”.
