Sap Quality Management Consultant

2 weeks ago

New Delhi, India Etenico Technologies Full time

Role Summary We are seeking a SAP QM Architect with strong pharmaceutical and life sciences domain experience to lead the design and development of GxP-compliant Quality Management products and extensions on the SAP S/4HANA and BTP platform.This role focuses on building reusable, validated product components—not just implementing solutions. You will work with SAP engineering and product teams to conceptualize and deliver digital quality solutions that are scalable, compliant, and aligned to GMP, GAMP 5, and 21 CFR Part 11 standards. Key Responsibilities Lead product design and architecture for SAP QM modules and industry cloud apps targeting GxP environments. Translate pharma quality processes (In-Process Inspection, CAPA, Deviation, Stability, COA) into configurable SAP product features. Build validation-ready product artifacts including audit trail, e-signature, and data integrity frameworks. Collaborate with product managers, domain SMEs, and developers to translate regulatory requirements into product functionality. Define standard APIs and integration templates for LIMS, MES, and DMS via SAP BTP/CPI. Contribute to functional specifications, UI/UX design, and end-to-end validation of new product releases. Ensure all builds adhere to GxP compliance and product lifecycle management best practices. Required Experience & Skills Relevant 10–15 years in SAP QM; 5+ years in GxP-regulated pharma or life sciences. Proven experience in SAP product development, co-innovation, or accelerator builds. Deep knowledge of Inspection Planning, Sampling, Results Recording, CAPA, Stability, and COA generation. Strong understanding of CSV, audit trail, and validation documentation (IQ/OQ/PQ). Hands-on with SAP S/4HANA, BTP, CPI, and Fiori/UI5. Exposure to Agile product lifecycle, CI/CD pipelines, and release management preferred. Education & Certifications • Bachelor’s/Master’s in Engineering, Life Sciences, or Pharmaceutical Sciences. • SAP QM Certification or GxP/CSV/GAMP 5 credentials preferred. Why This Role Matters You will be part of a global product team that builds the next generation of SAP Quality solutions—bridging SAP innovation with regulated manufacturing needs. Your designs will shape how pharma manufacturers achieve digital, compliant, and audit-ready quality operations worldwide.

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