Sr Manager, Application Development

• 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 Maintece / Asset Management (PM/EAM).
  • Extended Warehouse Management (EWM).
  • Fice 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 bachelors or masters 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.

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