Dionysia Rigopoulou
Quality Information System Analyst @Eisai EMEA
Signup · Get unlimited contacts
WORK HISTORY
Quality Information System Analyst @Eisai EMEA
Hatfield, GB
Part of the Global Digital Business Transformation team - key link between IT and business units (Quality Control, Manufacturing and Quality Systems), supporting the delivery, maintenance, and continuous improvement of GxP-regulated IT systems.Support the implementation and lifecycle management of IT systems aligned with GMP regulations, including LabVantage LIMS -Subject Matter Expert (SME), CDS (Chromeleon), and Quality Control equipment/software.Provide BAU technical support via ServiceNow, collaborating with infrastructure, security and support teams to resolve issues, implement system changes, and optimise service performance.Participate in computerised system validation (CSV) activities, including validation planning, protocol authorship (ITIQ, IQOQ, PQ), execution and documentation in accordance with GAMP 5 and 21 CFR Part 11.Coordinate and author documentation for GxP-IT change control, impact assessments and deviations/CAPAs to ensure data integrity and audit readiness.Gather and translate business requirements into technical specifications, contributing to application design, system testing and compliant implementation of quality systems.Liaise with external vendors and system providers, ensuring that all solutions align with internal specifications, cybersecurity best practices and regulatory expectations.Use Jira platform for vendor communication, issue tracking and build delivery; manage internal project workflows and progress through Monday.com.
EDUCATION
University of Patras
Master's degree, Chemical Biology
University of Patras
Bachelor's degree, Chemistry
ABOUT DIONYSIA RIGOPOULOU
I work as a Quality Information System Analyst supporting digital transformation and GxP IT systems within the pharmaceutical industry.Currently part of Eisai’s Global Digital Business Transformation team, I serve as a bridge between IT and business teams (QC, QA, Manufacturing), supporting the implementation, validation and lifecycle of quality systems like LabVantage LIMS (SME). I work across digital projects, CSV, change management and data integrity to deliver efficient, compliant solutions in regulated environments.My background in chemistry and hands-on experience in GMP laboratories have given me a strong understanding of analytical testing, workflows, system usage, and regulatory requirements—insight I now apply to enhancing system performance, compliance and user experience.
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.