Technical Consultant
7 days ago
MUST HAVES;
Experience with performing design testing of application to help author SDLC documents, including SDCS, URS, FRA, Admin Sop, IQ, IOQ, ATR, Application Data Flow diagrams, etc.
More than 5 years relevant IT/business experience, analysis, and documentation
of business and technical requirements (required) Experience with software application implementations in GxP environment(required)
IT Experience deploying and supporting Quality and Manufacturing Systems
including Analytical Instruments Empower, Chromeleon, SOLO VPE, GEUnicorn, Nova Biomedical Bioprofile CDV and Flex2, Roche Cedex, Roche
LightCycler 480, FileMaker Pro, Bartender, Charles River EndoScan-V, GE
DataPro2, Informait InForm/CC, Lonza WinKQCL, Mettler Toledo LabX,
PerkinElmer Asset Genius, Thermo WebAdmin for TruScan RM Analyzer, and
various Laboratory desktop applications used in GxP environment
Experience with Computerized Systems Validation (CSV), 21 CFR Part 11
regulations, and Data Integrity compliance
Experience working with ITIL processes in ServiceNow such as Incident
Management, Change Management, Problem Management, Asset and
Configuration Management (CMDB)
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