Experience

Iarnród Éireann Irish Rail

• Ireland
• Rail Transportation
• 700 & Above Employee

• Document Controller/Administrator Officer Cork Area Commuter Rail Programme

  • Jan 2023 - Present



HIQA - Health Information and Quality Authority

• Ireland
• Government Administration
• 100 - 200 Employee

• Document Control Specialist

  • Nov 2015 - Jan 2023



GSK

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Compliance Data Administrator

  • Sep 2015 - Nov 2015



GE Healthcare, Carrigtwohill, Co Cork

• QA Computerised Software & Instrumentation Specialist, Quality-Global

  • Jan 2010 - May 2014

  Computerised Systems Validation Provide guidance and instruction to project teams and sites as to the required deliverables to ensure compliance of a computerised system or process. Perform Internal or external Audits related to CSV as a member of the audit team. Educate and train engineering/operations/quality to ensure adoption of CSV best practices. Review and Approve project documentation throughout project/system development and implementation to ensure compliance with regulatory expectations. Perform Testing. Trackwise Global System Administration Provide Inspection Readiness support. Provide controlled access and rights to nominated users in compliance with 21CFRPart11 Responsible for day to day activities and help-desk service for users both locally and globally



GE HealthCare

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Site Lead, DeCO Document Management Project

  • Apr 2007 - Jan 2010

  Part of the Global Design Team for the Document Management SystemProject ManagementManaged the project from design phase to implementation with responsibility for Migration,Validation and training of 300 users

• System Administrator

  • May 2002 - Apr 2007

  Manage and maintain (eDMS) system for R&D and manufacturing funtions in a GxP compliant manner.Provide continuous training programme for new and existing users.Manage a programme of system upgrades both globally and locally.Helpdesk support globally.

• Compliance Officer

  • May 2000 - May 2002

  Coordinate internal and external audit procedures.Manage Customer compliants and change control systems.Facilitate the introduction and launch of any automated QA systems

• Document Control Officer

  • Nov 1997 - May 2000

  Process owner of company documentation system.Training of personnel on documentation systemsSupervising of Documentation Control GroupParticipating in compliance audits

• QA Assistant

  • Sep 1995 - Nov 1997