Deputy Manager, Application Development

Responsibilities

• 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.

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.

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