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SG-WAUGC

CSV & IT Quality consultant

Spain (Serbian)
Seniority:
Offering Long-term Freelance Contract
Seeking Permanent Employment
Industries: Life Sciences
Price (MD)
0
€ 61 - € 82
Annual salary
0
€ 100,000 - € 110,000

Summary

Experience:
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 GEP
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

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