SAP QM Gxp Consultant - Pharmaceutical

An experienced SAP PP & QM Consultant with strong expertise in SAP S/4HANA (RISE with SAP) and deep understanding of GxP-regulated pharmaceutical environments. The candidate will play a key role in delivering compliant, validated, and scalable manufacturing and quality management solutions aligned with global regulatory requirements.

The consultant must have hands-on experience in Greenfield S/4HANA implementations, validation lifecycle management, and integration with regulated systems (MES, Serialization, etc.).

Key Responsibilities

SAP PP (Production Planning)

• Configure and implement:
• Master Data (BOM, Routing, Work Centers, Resources)
• MRP, MPS, and Capacity Planning
• Process Orders / Production Orders
• Batch Management
• Demand Management & Planning Strategy
• Integration with MM, WM, SD, and FI
• Experience in regulated batch manufacturing environments
• Understanding of process industries
• Knowledge of:
• Fiori Apps & Role-based access
• Embedded Analytics
• Business Process Intelligence
• SAP Activate methodology
• Support Fit-to-Standard workshops
• WRICEF identification and design
• Knowledge of:
• Fiori Apps & Role-based access
• Embedded Analytics
• Business Process Intelligence
• SAP Activate methodology
• Support Fit-to-Standard workshops
• WRICEF identification and design

SAP QM (Quality Management)

• Configure and implement:
• Quality Info Records
• Inspection Planning (Incoming, In-Process, Final)
• Usage Decision & Quality Notifications
• Batch Release Process
• Stability Studies (preferred)
• Integration with PP, MM, and WM
• Electronic Batch Record (EBR) integration exposure
• Experience in audit-ready documentation

GxP & Pharma Compliance Responsibilities

Strong knowledge of:

• GMP / GDP warehouse practices
• GAMP 5 principles
• 21 CFR Part 11 requirements
• Electronic records & audit trail controls
• Temperature-controlled inventory handling
• FEFO (First Expiry First Out) strategy
• Batch traceability & genealogy
• Controlled substance handling (preferred)

Experience in:

• Computer System Validation (CSV)
• Validation documentation (URS, FS, DS, IQ, OQ, PQ)
• Risk-based validation approach
• Working closely with QA & Validation teams
• Supporting regulatory audits (FDA / EMA / MHRA preferred)

Key Functional Scope

• Inbound logistics (GR from PO / Production)
• Quality inspection stock handling
• Blocked & restricted stock processes
• Quarantine management
• Batch release coordination with QM
• Outbound logistics (picking, packing, shipping)
• Integration with serialization systems (if applicable)
• Temperature & storage condition control processes

Required Skills

• 12+ years SAP PP & QM experience
• Minimum 2 full lifecycle greenfield S/4HANA implementations in Pharma Industry - RISE with SAP Private Cloud
• Pharma or Life Sciences industry experience (mandatory)
• Strong integration knowledge (PP-QM-MM-FI)