On a medical-device company project, I managed the validation of Polarion ALM and an IT infrastructure qualification project. I created the required lifecycle documentation and coordinated project teams and stakeholders.
I also managed IT application migration and cutover for pharmaceutical divestitures, preparing documented evidence of handovers and reporting to steering committees.
For a medical-device company, I defined CSV and ESV strategy, created validation documentation, and supported the local QM/QA team in preparation for audits.
My work spans regulated life-sciences IT, including computer system validation, quality management, IT service management, and security. I hold CISA, ITIL v3, and PRINCE2 certifications.

