Be Inspired Series
Took a degree in biological sciences at University of Ulster and also completed a one year diploma in industrial studies. On graduation, worked with an API manufacturer in quality assurance before moving to Almac eight years ago
What does your job entail?
My job as a Qualified Person (QP) within Almac is to certify and release batches of medicinal product to clinical trials and for commercial supply.
The term QP is used across the EU and regulations specify that no batch of medicinal product may be released for supply prior to being certified by a QP who is typically a pharmacist, chemist or biologist. In effect this means that QPs are responsible for ensuring the quality, safety and efficacy of each batch of product.
Is it 9-5?
My job is generally 9-5ish, however, the days can vary widely depending on clients' requirements to ensure that the product gets released in line with customers' orders and expectations.
How did you get into this line of work?
While studying at University of Ulster, as part of my degree in biological sciences I also completed a one year diploma in industrial studies which involved working as a production operator in a small API manufacturer just outside Coleraine. This was my first introduction to the world of pharmaceutical manufacturing.
Outline your career to date?
On completion of my degree I was given the opportunity to return to the API manufacturer in a quality assurance role. I then moved to a sterile manufacturing facility in Larne where I continued in the quality assurance field before moving to Almac in Craigavon almost eight years ago.
I started off as a quality compliance officer and progressed to a senior quality compliance looking after the day-to-day function of the QA department. After completing the requirements to become eligible to act as a Qualified Person I was added to our manufacturing licence in early 2011.
Tell us about your qualifications/training.
I completed the Irish Leaving Certificate in 1998 followed by a BSc (Hons) biologicalsScience with University of Ulster, Coleraine.
Throughout my time at Almac I have been provided with opportunities to develop and grow professionally through various internal and external training courses applicable to my role.
Almac also sponsored my training programme to enable me to become a QP through a course run by a professional training provider in the UK. Over a two year period I attended 12 modules with an examination taken for each module.
At the end of the course I submitted my application for assessment by the Joint Professional Bodies of the Royal Pharmaceutical Society, the Royal Society of Chemistry and the Society of Biology, bodies which determine your eligibility to act as a QP by an interview assessment conducted in London.
Throughout this time Almac provided both financial and moral support to enable me to achieve a positive outcome.
What qualities are required for your job - personal and professional?
From a professional perspective QPs have legal, moral and ethical obligations to ensure that only safe products are released. From a personal perspective you need to be level-headed, assertive and apply a common sense approach to the many day-to-day problems and issues which arise during manufacture and testing of medicinal products.
What is the best advice you ever received?
My parents always made me believe in myself and consider that anything is possible if you work hard and put your mind to it.
On a day to day basis I think of the wise advice I was once given - 'when releasing a batch always consider how you would feel if you or a member of your family were prescribed it.'
Tell us an interesting fact about yourself.
I’m from Donegal originally and represented the North West Ulster Hockey team while attending the Royal and Prior School, Raphoe.
Who has inspired you most in your life?
Although she probably doesn’t know it my biology teacher was the person who first encouraged my interest in the world of science. I had originally planned to become a biology teacher but after my introduction to pharmaceutical manufacture decided to go down that route instead.