Description

You will manage computer system validation and quality management activities within GxP application environments.

Responsibilities

• Guide project teams through the SDLC by defining applicable deliverables based on project type and category.
• Apply FDA guidance and industry standards, such as GAMP, to all validation activities.
• Analyze service technologies to determine GxP classification and data attribute hierarchies.
• Design and implement a mapping structure for services using SharePoint Lists.
• Develop reporting mechanisms to track progress, technology identification, and CMDB GxP classification status.

Required Skills

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

Preferred Skills

• Experience managing complex data mapping from spreadsheets to centralized tracking structures.

Key Skills

Education

Any Graduate