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 over 15 years validation experience across the pharmaceutical, biotech and consumer health industries.
I have worked on numerous projects implementing new manufacturing and filling facilities including cleanroom design, commissioning and qualification, sterilisation and decontamination processes, cleaning validation, aseptic filling processes, controlled storage environments and controlled transport validation by road, air and sea.
I can provide advice of current best practices, documentation and hands on validation execution as required by the client.
I have worked on numerous projects implementing new manufacturing and filling facilities including cleanroom design, commissioning and qualification, sterilisation and decontamination processes, cleaning validation, aseptic filling processes, controlled storage environments and controlled transport validation by road, air and sea.
I can provide advice of current best practices, documentation and hands on validation execution as required by the client.
I have extensive multi discipline experience within the life sciences industry, including validation, quality risk management, continuous improvement and manufacturing.
I have led the validation of projects that range from new facilities, technical transfer of products between sites, and delivery of new products to market for both startups and the world’s largest pharmaceutical organisations.
The skills I have picked up in these roles together complement each other, bringing the most value to the people I have worked for. At ParagonV I aim to bring the best value to its customers, continuing to be results focused, whilst delivering compliant projects.
I have led the validation of projects that range from new facilities, technical transfer of products between sites, and delivery of new products to market for both startups and the world’s largest pharmaceutical organisations.
The skills I have picked up in these roles together complement each other, bringing the most value to the people I have worked for. At ParagonV I aim to bring the best value to its customers, continuing to be results focused, whilst delivering compliant projects.
I have 10 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.