Job role: SAP QM Consultant with Pharma
Experience: 8 yrs and above
Location: UK
Onsite : Work from Office
🧪 Role Summary
An SAP QM Consultant specializing in the pharmaceutical sector designs, configures, implements, and validates the SAP QM module tailored to GMP/GxP-regulated environments. The consultant ensures quality processes—from inspection planning through batch release—are integrated into S/4HANA, supporting compliance and operational excellence
Tasks
Pharma‑Specific Responsibilities
- Ensure GxP/GMP compliance throughout SAP QM processes.
- Translate pharma quality processes (inspection, CAPA, deviation, stability, COA) into SAP QM workflows.
- Enable integrations with LIMS, MES, and DMS systems, supporting regulatory alignment.
Skills & Competencies
- Deep knowledge of pharma quality processes: inspection planning, deviation, CAPA, stability, COA, batch release.
- Proficient in documentation: business requirements, functional specs, test scripts, SOPs.
- Excellent stakeholder management, workshop facilitation, and communication skills.
- Strong analytical, problem-solving, and process improvement mindset.
- Ability to guide validation activities, ensure audit-readiness, and support compliance.
- Coaching and training capabilities for end-users.
Requirements
Key Responsibilities
- Lead the design, configuration, and implementation of SAP QM aligned with pharmaceutical industry standards and regulatory compliance.
- Configure QM master data: inspection types, sampling procedures, quality notifications.
- Facilitate workshops with stakeholders to capture requirements and translate them into functional specs.
- Integrate SAP QM with modules like MM, PP, WM, EWM, and compliance systems (LIMS, MES, DMS via BTP/CPI where relevant).
- Define inspection planning, in-process controls, batch release, deviation/CAPA handling, and stability/COA processes.
- Support validation and documentation (CSV, IQ/OQ/PQ, test scripts, SOPs, audit trail, e-signatures).
- Participate in integration testing, UAT, cutover, hypercare, and offer post-go-live support.
- Identify process improvements and recommend SAP QM best practices for pharma.
- Develop and deliver training materials; support audits and compliance checks.