Senior Manager, Application Development

Overview
Amneal Pharmaceuticalsamneal.comPosted 5 weeks ago
Ahmedabad, Gujarat, INمن مقر العمل
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مستوى الخبرة
Senior
نوع الوظيفة
دوام كامل
التخصص
Backend engineering

نبذة عن الوظيفة

  • 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.

Key skills

  • SAP
  • Production Planning
  • Warehouse Management
  • QA
  • Supply Chain