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Experience:o Experienced in working on IT projects within multicultural, global or virtual project teams in a matrix environmento Proficient in scaling validation activities and deliverables based on System Risk Analysis o Skilled in Waterfall and Agile project Management Methodologyo Experienced in maintaining system in validated state by change/configuration management and periodical reviewso Knowledgeable in regulatory norms and guidelines: GAMP 5, EudraLex Vol 4 Anex 11, FDA CFR 21 part 11 and 820, ISO 9001, and GEPo Experienced in ITIL Processes, KPIs and operation metricso 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 Documentumo ITSM - ServiceNow and HP SM o Global Information Systems: SAP, SalesForceo MS Office, Office 365, MS Project, Visio Professional, SharePointo MindManager Enterprise
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