Cristian-Bogdan Dragomir

Validation lead in a major factory upgrade project with several workstream. One workstream covered the migration of a Manufacturing Execution System (MES – Syncade) and that of a historian from OsiSoft/Aveva PI from a legacy IT infrastructure to a new Hyper-Converged Infrastructure. The second workstream consisted in the upgrade and migration of DeltaV including a hardware replacement where DeltaV PK controllers and Profibus cards were installed to provide redundancy and high availability in the Process Control System. As a validation lead for these workstream I ensured that the migration and upgrade followed client’s SOPs and GxP regulatory requirements. Responsible for validation planning/reporting and all the processes in between: risk assessments, design reviews, data migration planning/reporting, FAT & SAT.

Responsible for the GxP IT Operations of several global IT systems. Typical responsibilities were supplier GxP audits (Cornerstone and eConsulting) to ensure that their services meet regulatory requirements or to identify compliance gaps. Furthermore, performing Periodic IT Reviews to ensure the validated state of systems, Patch & Release management, Configuration Management, Change Management. Focus was also on optimizing the operations by using a risk-based approach to reduce the documentation effort while increasing quality output. The Primary supported systems were: Cornerstone LMS, Adobe Sign, Workday.

Managing the analysis phase for updating the IT QMS of the client, including the processes and work instructions around their Test Management Tool, Azure DevOps. The tasks consisted in organizing and facilitating workshops with relevant QA stakeholders for collecting and consolidating ideas on areas of improvement. Moreover, to collect requirements for a potential new test management tool suitable for the needs and future growth of the company.