Csv Consultant

Job Description IT CSV Team Member

Position Details

• Job Title: IT CSV Team Member SAP
• Function: Information Technology / Computerized System Validation (CSV)
• Industry: Pharmaceutical / Life Sciences
• Experience: 8+ years
• Employment Background: Experience from pharmaceutical, product-based, consulting, or IT service organizations

• Execute CSV activities for SAP implementation, enhancement, upgrade, integration, and support projects.
• Participate in validation planning and determine validation requirements based on system criticality, intended use, GxP impact, and risk.
• Support preparation, review, and approval of validation deliverables such as:
  
• Validation Plan / Master Validation Plan inputs.
• GxP and system impact assessments.
• Computerized System Risk Assessments.
• User Requirements Specifications (URS).
• Functional and Design Specifications, where applicable.
• Requirements Traceability Matrix (RTM).
• Test plans, test scripts, test protocols, and test evidence.
• Installation, Operational, and Performance Qualification documentation, where applicable.
• Validation Summary Reports.
• Standard Operating Procedures and Work Instructions.