Job 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 clear, 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, reconciliation, error handling, and audit trail.
• Assess and document data integrity controls including ALCOA+ principles, audit trails, electronic records, electronic signatures, access controls, and record retention.
• Support evaluation of SAP roles, authorization controls, segregation of duties, and privileged access where relevant to GxP processes.
• Participate in SAP data migration validation including source-to-target mapping, data verification, reconciliation, completeness, and accuracy checks.
• Support assessment and validation of SAP master data and transactional data impacting regulated business processes.
• Participate in validation of applicable SAP modules/processes such as:
• Materials Management (MM).
• Production Planning (PP).
• Quality Management (QM).
• Plant Maintenance / Asset Management (PM/EAM).
• Extended Warehouse Management (EWM).
• Finance and Controlling where GxP relevance exists.
• SAP Fiori applications and workflows.
• SAP integrations and interfaces.
• Work with SAP functional and technical teams to ensure validation requirements are embedded throughout the system development lifecycle.
• Support change controls and perform GxP/validation impact assessments for SAP enhancements, configuration changes, patches, upgrades, and releases.
• Support periodic reviews of validated SAP systems to confirm continued validated state.
• Support incident, problem, deviation, CAPA, and change-management processes affecting validated systems.
• Assist in maintaining validation documentation throughout the system lifecycle and ensure controlled documentation is current and audit ready.
• Support system decommissioning and archival activities where required.
• Participate in internal audits, regulatory inspections, customer audits, and supplier audits involving computerized systems.
• Provide validation documentation and evidence during inspections and respond to auditor/inspector queries as required.
• Ensure validation activities comply with organizational SOPs, Quality Management System requirements, and approved project methodology.
• Coordinate with Quality Assurance for review and approval of validation documents and resolution of compliance observations.
• Support qualification and assessment of SAP vendors, System Integrators, cloud/service providers, and third-party technology suppliers where applicable.
• Promote standardized CSV practices and consistent validation methodology across SAP projects and geographical locations.
• Identify validation risks early and escalate gaps that may impact regulatory compliance, data integrity, testing, or project go-live readiness.
• Any bachelor's or master's degree from a recognized institution.
• SAP certification in any relevant functional or technical area is preferred but not mandatory.
• CSV, GAMP 5, Quality, ISPE, or regulatory compliance certification is advantageous.
• Experience with SAP S/4HANA, particularly Cloud Private Edition or large-scale global SAP transformation programs, is preferred.
• Experience in pharmaceutical manufacturing, quality, warehouse, supply chain, laboratory, or regulated business processes is desirable.