CSV Engineer

Note : The resource must have experience in Microsoft Sharepoint and Power Platform tools, data analytics and dashboarding.

Job Details :

• 8+ years' experience in Computer System Validation or Quality management or Business Analysis in GxP application area.
• Guide the project team with the right set of applicable project deliverables based on project type and category while catering to the SDLC.
• Application of FDA guidance and industry standards (i.e., GAMP). Strong understanding of 21 CFR Part 11 and Risk Based Approach with the ability to guide the project teams.
• Possesses strong communication skills to interact with business stakeholders (Technology Leader, Project Manager, Business Owner & Business users / SME) and interpret business rules and requirements and documents.
• This resource will support the following related to our Service Industrialization (SI) project :
• Review the Services SI excel spreadsheets for tools, applications and other technologies required to provide the service. There are about 21 spreadsheets.
• Design and set up Mapping Structure for TS Services in SharePoint List.
• Record the technologies from the excel spreadsheets in the Mapping Structure for each Service.
• Collect the CMDB information for each technology pulled from the spreadsheets.
• Analyze technologies collected manually for GxP classification.
• Analyze hierarchy and data attributes for Services.
• Set up reporting to communicate status of progress Services supporting GxP use cases, Services' technologies identified, Services' technologies CMDB, GxP classification status.

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