SAP GxP

Kannanware

  • Tamil Nadu
  • Permanent
  • Full-time
  • 20 days ago
JD : Sector Public RTH- Y Position 1 Role Title: SAP GxP Consultant Band: 7B / 8 Location:(PAN India) Role Overview SAP GxP Consultant to support a critical SAP S/4HANA migration program. The consultant will ensure all project activities meet GxP, regulatory, and audit compliance requirements, while supporting design, validation, testing, and deployment activities across SAP modules. Key Responsibilities Ensure that all SAP S/4HANA migration activities comply with GxP, CSV (Computer System Validation), and regulatory guidelines (FDA, EMA, MHRA, etc.). Participate in Fit-Gap analysis, process workshops, and system design with a compliance‑first approach. Review and validate functional specifications, design documents, configuration documents, and ensure adherence to GxP practices. Support creation and execution of IQ/OQ/PQ scripts, validation plans, traceability matrices, and testing documentation. Collaborate with business, QA, and technical teams to ensure audit‑ready documentation. Conduct risk assessments, deviation management, and compliance monitoring throughout the migration lifecycle. Provide support during UAT, cutover, hypercare, and change management activities. Ensure all migration objects, configurations, and processes are aligned with GxP standards. Prepare for internal and external audits, CAPA tracking, and ensure compliance closure. Key Competencies 5–10+ years of SAP experience, with at least 3+ years in GxP or Pharma/Life Sciences regulated projects. Strong understanding of GxP standards, CSV process, and regulatory guidelines. Hands‑on experience with SAP ECC to S/4HANA migrations. Deep knowledge of one or more SAP modules: SAP MM / WM / PP / QM / SD / PM / FI / CO (as per need) Experience preparing validation documentation: URS, DS, FS, Test Scripts, Traceability Matrix, Validation Plans. Strong understanding of data migration, interfaces, and change control processes. Ability to work closely with multiple stakeholders and communicate clearly wit

Kannanware

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