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ABOUT US

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EVA KELLY

Eva has a degree in Analytical Science and a PhD in Chemistry from Dublin City University. She has over 25 years of site solutions and learning management experience across pharmaceutical, medical device, industrial, veterinary and FMCG sectors. Eva has worked as a Data Integrity SME specialising in 21 CFR Part 11 and Annex 11 compliance and held Data Integrity lead and QA IT lead positions for pharma and biotech companies utilising GxP SAAS, hosted and on-premise solutions. She has been involved with many international  DI remediation  projects with significant positive outcomes.

 “I am passionate about growing the right site DI culture and striving towards a culture of Excellence and enjoy working directly with clients to achieve this cultural goal. Establishing a Data Integrity Governance strategy that recognises people, processes and automation (technology) as key enablers of data integrity compliance is essential and ensuring that DI culture is fundamental within this key framework document is crucial to site DI long term success.”

Over the last 10 years I have specialised in stakeholder presentations, Application Lifecycle Management (including system and method validations, transfer and troubleshooting), Quality Risk Management, Application of POLP analysis to identify critical Data Integrity gaps and have gained considerable experience during implementation projects on SABA Cloud (VEMS), EtQ Reliance, VEEVA Vault QMS and Documentation Management, Axway Track and Trace for Serialisation, Rockwell PCS and various laboratory systems including Waters Empower, Vankel Dissolution, Agilent Chemstation and Dionex Chromeleon.

As Data Integrity continues to evolve it is now a fundamental requirement to fully understand what and where your original GxP records reside - I would be delighted to help you with this journey of understanding and provide you with support and collaboration tools to give you the best customer outcome.

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ANDY O'CONNOR

Andy has an honours degree in Science from University College Dublin. He has over 10 years of Enterprise Application Lifecycle Management experience across the Life Sciences sector. Career experience covers a spectrum of Validation Lead, QA IT Lead to Programme Management. He has collaborated on numerous Data Integrity projects for 21 CFR Part 11 and Annex 11 compliance and held both CSV and QA IT lead positions for GxP SAAS, hosted and on-premise solutions.

Andy has significant experience in Risk Management and Risk Perception and regularly hosts Risk Workshops on behalf of clients. He is an experienced LIMS and Empower practitioner and has held an IT administration role in several large multinationals.

 “The implementation of new technologies can be a major challenge in any quality critical organisation, where the unknown pains a new approach might bring leads to people's reluctance to change. Using collaborative sprint worksessions and investigating pains and gains through risk removes stakeholder barriers to propel the project forward”

I am passionate about using lean methodologies and embracing change to gain product and process efficiencies. Design Sprint thinking first developed by Google can play a significant role in pharma and biotech companies and allow you to attain Industry 4.0 goals and I would be delighted to collaborate and support you using these innovative methodologies.

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BEN O'BRIEN

Ben has an honours  degree in Chemical and Pharmaceutical Sciences from Dublin City University. He has worked within Pharma for over 7 years and held several  roles in Quality with a focus on SAAS and hosted QMS and LMS Applications. He has been involved in several large scale GxP  implementation projects and has experience in both quality and  validation deliverables. 

 

Leaving a management role in Pharma to join ERA Sciences, Ben is driven to excel and seek new opportunities. He is skillful at technical development and assessment aspects of Application Lifecycle Management (ALM), a keen innovator and was  an early advocate of paperless validation. Ben’s ease at picking up new applications, and previous experience with paperless Validation Solutions is well matched with his interest in implementing QA best practice to software applications. 

 

He is very interested in the application of new trends in ALM but equally comfortable working within Waterfall or Agile Methodology frameworks. Recent experience includes data migration, validation test execution and coordination activities associated with Veeva QMS  implementation team at a growing Life Sciences company. 

 

Ben brings a renewed focus and energy on lean methodology to the team. 


‘Software QA test automation is an established solution for software development but this as  an emerging opportunity for ALM in the Pharmaceutical industry - let’s get started’

LOCATION

112-114, Court C, Ardilaun Court, Suite 913 The Greenway | St Stephen's Green | Dublin | D02TD28 | IRELAND

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