PharmaLex in Ireland

I was interested in joining PharmaLex as I had worked with them when I was in industry and knew that their priority was providing robust solutions to some of the common challenges currently facing the Pharmaceutical Industry. PharmaLex brought a practical hands-on approach to issues and challenges and gave our team a different perspective.  Joining Pharmlex gave me the opportunity to really use my experience while still providing me with many learning opportunities to expand that experience. I love the variety in my role and working with many different people in the industry.

My undergraduate degree was in Industrial Microbiology and my Microbiology knowledge and experience underpins everything I do. This foundation has been invaluable when working with clients involved in Steriles, Biologics, Vaccines and ATMPs. I also have an MSc in Pharmaceutical Quality Assurance which expanded my Pharmaceutical education and allowed me to branch out from Microbiology into other areas of Pharmaceutical Quality. This MSc included a Thesis on Quality Risk Management which is now an area of expertise for me and something I am known to be passionate about!.  I also have a Post Graduate Diploma in Manufacturing Technology which allows me to be recognised as a Qualified Person in the EU and I have enjoyed my time as a practicing QP.

The landscape is changing in the Pharmaceutical industry as we start embracing novel technologies and I’m fascinated by personalised medicine and the impact these types of novel technologies will have on many traditional areas such as QC, QA, Sterility Assurance, Risk Management and QP disposition.. The direction the industry is taking will challenge all of us to move out of our comfort zones and that sort of challenge is always exciting. Also, the continued focus on Quality Risk Management continues to highlight the interdependencies between all the processes and systems in a pharmaceutical facility and working in this more holistic environment is very exciting when compared to the historical approach to Quality which was more siloed and removed from the heart of the pharmaceutical process.

With any change comes uncertainty and the biggest challenge I see in the industry is overcomplication of processes and procedures and a move away from effective simplicity. I often see very complicated processes and procedures that have become far removed from the basic principles of Quality or Risk. The challenge for the industry over the next number of years will be to peel away the complexity in areas where it isn’t required and become comfortable again with processes and procedures that are scientifically sound but easy to implement, follow and maintain. Unnecessary complexity becomes a burden and can be very difficult to manage long term.