- 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.