Description
- 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.
- Review SAP business and functional requirements to ensure applicable GxP, quality, regulatory, and data integrity requirements are adequately addressed.
- Ensure requirements are transparent, testable, traceable,



and appropriately linked to business and regulatory risks.
- Support risk-based validation and testing strategies to avoid unnecessary testing while ensuring adequate control of GxP-critical functionality.
- Review SAP configuration, custom developments, workflows, reports, forms, interfaces, conversions, enhancements, and integrations from a CSV/GxP perspective.
- Participate in SAP testing activities including:
- Functional testing.
- System Integration Testing (SIT).
- User Acceptance Testing (UAT).
- Regression testing.
- GxP/validation testing.
- Review executed test evidence for completeness, accuracy, traceability, objective evidence, and compliance with validation procedures.
- Ensure test deviations, incidents, and defects are documented, investigated, resolved, and appropriately assessed for GxP impact.
- Support validation of SAP interfaces with external or third-party applications and ensure appropriate controls for d

📌 Senior Manager, Application Development (Ahmedabad)
🏢 Amneal
📍 Ahmedabad