Deputy Manager, Application Development

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. 
  

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. 
  

Qualifications

• 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.