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