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.