• 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 data transfer

📌 Deputy Manager, Application Development (India)
🏢 Amneal India
📍 India