o Experienced in working on IT projects within multicultural, global or virtual project teams in a matrix environment

o Proficient in scaling validation activities and deliverables based on System Risk Analysis 

o Skilled in Waterfall and Agile project Management Methodology

o Experienced in maintaining system in validated state by change/configuration management and periodical reviews

o Knowledgeable in regulatory norms and guidelines: GAMP 5, EudraLex Vol 4 Anex 11, FDA CFR 21 part 11 and 820, ISO 9001, and ISO 13485

o Experienced in ITIL Processes, KPIs and operation metrics

o Skilled in Application and Infrastructure Release Management

Computer skills and competences:

o (ALM) suites – Micro Focus ALM (former HPALM) and JIRA 

o EDMS - Windchill and Documentum

o ITSM - ServiceNow and HP SM 

o Global Information Systems: SAP, SalesForce

o MS Office, Office 365, MS Project, Visio Professional, SharePoint

o MindManager Enterprise