Sap Quality Management Consultant

Job description

**Job Title: SAP QMS Consultant with CSV** Location : Bengaluru Work from office : Yes Experience : 7+ years Immediate joiners preferred Key skills : QMS, Computer System Validation (CSV), SAP QMS, Trackwise, 21 CFR Part 11, Pharma or Manufacturing domain experience. We at Coforge currently hiring SAP PP/QM Consultant with strong QMS and Computer System Validation (CSV) expertise in the pharmaceutical/manufacturing domain. The role involves supporting SAP implementations, ensuring compliance with regulatory standards, and managing quality systems aligned with GxP requirements. **Required Skills:** Domain & Compliance - 6–9 years of experience in **Pharmaceutical / Manufacturing domain** - Strong knowledge of **Quality Management Systems (QMS)** - Expertise in GxP, GMP, GDP compliance - Hands-on experience with: - 21 CFR Part 11 - EU Annex 11 - GAMP 5 - ICH Q9 (Risk Management) Computer System Validation (CSV) - Minimum 3–5 years of CSV experience - Experience in: - Validation lifecycle (V-Model / Agile) - Preparation & review of: - URS, IQ, OQ, PQ - Validation Plans & Reports - Traceability Matrix - Risk Assessments (FRA/IRA) - Hands-on validation of systems like: - Empower, Chromeleon, LIMS, SAP systems - Experience in 21 CFR Part 11 compliance & gap assessments SAP PP/QM Functional Skills - 3–5 years SAP PP/QM experience - At least: - 1 End-to-End implementation OR 2 support projects - Experience in: - SAP S/4HANA (implementation/migration/support) - PP & QM processes and integration with MM/SD - Ability to: - Translate business requirements into SAP solutions - Participate in design, build, testing, UAT, and support - SAP QMS processes and event management - LSMW - Basic ABAP debugging - Background jobs & variant configuration - Experience in SAP documentation: - BPD, FS, Test Scripts, UAT, SOPs - Exposure to integration with external systems / add-ons Quality, Validation & Audit - Experience in: - Change control, deviations & CAPA handling - Periodic review & monitoring activities - Audit support (internal, customer, regulatory) - Preparation and review of: - Risk assessments - Validation documents - User manuals & SOPs