Description

You will support the Service Industrialization project by managing data structures and reporting for GxP-classified technologies.

Responsibilities

• Design and implement a mapping structure for TS Services using SharePoint Lists.
• Review and migrate technology data from multiple Excel spreadsheets into the centralized mapping structure.
• Analyze collected technology data for GxP classification and evaluate service hierarchies and data attributes.
• Build and maintain dashboards to report on project progress, technology identification, and GxP classification status.
• Guide project teams on deliverables following SDLC, FDA guidance, and GAMP industry standards.

Required Skills

• 6+ years of experience in Computer System Validation, Quality Management, or Business Analysis within GxP application areas.
• Proficiency with Microsoft SharePoint and Power Platform tools.
• Strong background in Data Analytics and dashboarding.
• Deep understanding of 21 CFR Part 11 and Risk-Based Approaches.
• Experience applying GAMP standards and FDA guidance to project lifecycles.
• Ability to interpret complex business rules and requirements for stakeholders.

Preferred Skills

• Any Graduate degree.

Key Skills

Education

Any Graduate