Tracey Miller, Senior Quality Assurance Specialist at eXmoor Pharma Concepts Ltd, shares her experiences as a TOPRA apprentice.
Q: How did your career in regulatory affairs begin?
I started out in the pharmaceutical industry in 2005, working for Charles River Laboratories. I held various roles there, and then moved onto a company called Patheon in 2011, where I became more involved in development work. From there I moved into quality assurance, working for the blood service and supporting them with the development and manufacture of investigational cell and gene therapies. I'm still involved in cell and gene therapy quality assurance at eXmoor, supporting the team at our purpose-built facility while we prepare to obtain our MIA(IMP) licence.
I love regulations. I like finding out about them, reading them, and trying to interpret them. I enjoy it when you find that one says ‘one thing’, but it's also referencing these other three, so you start looking into them and comparing them all.
Q: Why did you choose the apprenticeship route?
While I was off on maternity leave, my boss messaged me to say: “There's an opportunity to do this apprenticeship – would you like to put yourself forward?” I read through the course planner and everything that was there, and I thought it sounded really interesting!
But, then I also thought to myself, “I've got a baby – how is this going to work?” However, it sounded so good that I just decided: “You know what? I’m up for this. I’m up for learning again!”
It was slightly terrifying because it had been a while since I'd done this sort of thing. I was hoping that it would complement the knowledge I already had and build on that, which it did.
Q: What do you like most about the apprenticeship?
My first face-to-face course was the ATMP module, and I really enjoyed that. I liked being in the room, doing the case studies with other delegates and being able to chat with the speakers. It was also great being able to get to know people and talk about the coursework to see how they were finding it. Getting different opinions and knowledge in that setting can be really helpful.
Q: How has the course helped you with your work?
The apprenticeship built on the knowledge that I already had, and really helped to expand it. It's also made me aware of the guidance that I hadn’t realised was available. There have also been occasions at work when something on the course has actually helped us.
Q: What would you say to someone considering the apprenticeship?
Level 7 apprenticeships are a lot of work and take a lot of time, but the more you do the more comfortable you get with it. It can be daunting at the start if you haven't been in education for a while, especially when you first sit down to do the coursework.
But once you start to move through it, you start building your knowledge and making friends. The networking is a really good aspect and I keep in touch with all the people that did the apprenticeship alongside me.
I was so proud when I finished mine. I found myself doing things I didn't even know I was capable of. It's just a really good thing to do as it opens so many new doors.
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