SAP S/4HANA PP & QM with Pharma & GXP experience - Contract

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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)

Soft Skills

  • Strong stakeholder management
  • Experience leading design workshops
  • Ability to work with global QA & compliance teams
  • Strong documentation skills
  • Consulting mindset with process-oriented thinking

Educational Qualifications

  • SAP Certification in **SAP S/4HANA Production Planning or Quality Management (preferred)

Project Exposure Expected

  • Greenfield Experience is Mandatory to S/4HANA
  • GxP validated SAP landscape
  • Integration with serialization and compliance systems

 

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