I have held various roles within the pharmaceutical sector with over 20 years’ experience. I have a wide range of experience which includes formulation development, process development, facility and equipment validation. As well as a broad knowledge of equipment validation in the pharma / bio pharma industries, I specialise in steriliser validation and cleanroom qualification and I am member of the Irish Cleanroom Society.
As a founding director of ParagonV I maintain a hands-on role in the delivery of validation strategies in accordance with current regulatory requirements.
As a founding director of ParagonV I maintain a hands-on role in the delivery of validation strategies in accordance with current regulatory requirements.
I have 14 years validation experience. I have a microbiology background which led me into sterilisation. I have experience with both start-ups and established pharmaceutical companies.
I have a disciplined and enthusiastic approach to achieving consistent high standards of work and thrive in high pressure situations. I have experience in completing risk-based rationales expected by the current validation guidelines and apply to planning, design and execution phases. I am able to quickly realise validation plans while considering regulatory requirements, equipment constraints, project flexibility and deadlines.
I have significant audit experience which has sat me in front of the MHRA, FDA, Ministry of Healthcare for Russian Federation and acted on behalf of clients in customer audits.