Qa.Is: Systems Specialist
CurrentMain responsibilites:IS/GxP system 'owner' for documentation, change control, CAPA and archive systems.Site QA/IS: quality approver of IS projects/validation/qualification.Several years experience in process/systems development, project management and experience in introduction of IS solutions and inter-site support functions.Major IS projects include:Electronic document management systemEvents & CAPA management systemChange Control management systemArchives… Show more Main responsibilites:IS/GxP system 'owner' for documentation, change control, CAPA and archive systems.Site QA/IS: quality approver of IS projects/validation/qualification.Several years experience in process/systems development, project management and experience in introduction of IS solutions and inter-site support functions.Major IS projects include:Electronic document management systemEvents & CAPA management systemChange Control management systemArchives management systemOther:Product transfersI have been directly involved in multiple agency audits in both back-room set-up and system fronting. Show less