SAP GxP Consultant (43923)

We are looking for an experienced SAP GxP Consultant to support and maintain SAP systems in a regulated pharmaceutical environment. The role focuses on GxP/GMP compliance, CSV and GAMP 5, validation documentation and close cooperation with quality and business stakeholders. The assignment is 50% allocation with an immediate start and is currently planned until the end of January.

🚀 Project
- ensure SAP systems and related processes comply with GxP regulations, GMP standards and internal quality procedures
- participate in SAP implementation, upgrade, rollout, validation and support projects
- prepare and maintain validation documentation including URS, FS, DS, IQ, OQ, PQ, risk assessments and traceability matrices
- support CSV activities in line with GAMP 5 and FDA/EU regulatory expectations
- work closely with Quality Assurance and business stakeholders during audits and inspections
- perform impact assessments for system changes, deviations, CAPAs and change controls
- support SAP modules such as QM, MM, PP, WM, EWM and SD, including related integrations
- assist with SOP creation, training documentation and end-user support
- coordinate functional, regression and user acceptance testing
- ensure data integrity and compliance with ALCOA+ principles
- collaborate with global and local teams on continuous improvement initiatives

🎯 Skills
- 3+ years of SAP consulting experience in pharmaceutical, biotechnology or life sciences
- strong knowledge of GxP, GMP, GAMP 5 and CSV
- knowledge of FDA 21 CFR Part 11 and EU Annex 11
- hands-on experience with SAP environments in regulated settings
- experience with validation lifecycle documentation and audit support
- strong analytical, communication and stakeholder management skills
- English C1

💡 Nice to have
- experience with S/4HANA migration or implementation projects
- knowledge of data integrity and cybersecurity principles in regulated environments
- experience working in international or multicultural teams

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