You will be taken to Amneal’s own careers page to apply. Job ID 9295.
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.
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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.
Required Experience & Skills
Minimum 8+ years of overall IT/CSV/SAP experience, preferably within pharmaceutical, biotechnology, medical device, healthcare, or other regulated industries.
Strong hands-on experience in Computerized System Validation for SAP systems.
Practical understanding of SAP implementation and application lifecycle activities.
Experience supporting at least one full SAP implementation, upgrade, rollout, or major transformation program preferred.
Good understanding of pharmaceutical GxP business processes and associated computerized-system controls.
Working knowledge of applicable regulations and guidance, including:
US FDA 21 CFR Part 11.
EU GMP Annex 11.
GAMP 5 principles and risk-based validation.
Data Integrity / ALCOA+ principles.
Applicable GxP and Good Documentation Practices.
Experience preparing and reviewing validation lifecycle documentation.
Hands-on experience with risk assessment, requirements management, traceability, testing, deviation management, and validation reporting.
Good understanding of SAP configuration versus custom development and associated validation risks.
Understanding of SAP interfaces, data migration, security, authorization, audit trails, and master-data controls.
Experience with validation/document management tools such as ValGenesis, Kneat, OpenText, HP ALM, Jira, SAP Cloud ALM, Solution Manager, or equivalent is desirable.
Ability to interpret technical and functional SAP documentation from a regulatory and quality perspective.
Strong analytical and documentation skills with attention to accuracy, traceability, and compliance.
Ability to work effectively with business, Quality Assurance, IT, SAP functional/technical teams, System Integrators, and external vendors.
Good communication, stakeholder-management, and problem-solving skills.
Ability to manage multiple validation deliverables and priorities within project timelines.
Requirements
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.
