SAP GxP Consultant (43923)

A regulated pharmaceutical environment is expanding its team with an SAP GxP Consultant who will ensure that SAPsystems and processes comply with GxP requirements, regulatory standards and quality policies. The role covers validation documentation, CSV activities in line with GAMP 5, impact assessments and close collaboration with business, QA, validation and IT teams. At least 3 years of SAP consulting experience in pharma or life sciences and knowledge of GMP, FDA 21 CFR Part 11 and EU Annex 11 are required.

🚀 Project
- Ensuring SAP systems and processes comply with GxP, GMP and internal quality procedures
- Participation in SAP implementation, upgrade, rollout, validation and support projects
- Preparing and maintaining validation documentation (URS, FS, DS, IQ, OQ, PQ, risk assessments, traceability matrices)
- Supporting CSV activities in line with GAMP 5 and FDA/EU regulatory expectations
- Working with Quality Assurance and business stakeholders, including during inspections
- Impact assessments for system changes, deviations, CAPAs and change controls
- Supporting SAP modules such as QM, MM, PP, WM, EWM, SD and related integrations
- SOP creation, training documentation and end-user support
- Coordinating functional, regression and user acceptance testing
- Ensuring data integrity in line with ALCOA+ principles
- Collaborating with global and local teams on continuous improvement

🎯 Skills
- 3+ years of SAP consulting experience in pharmaceutical, biotechnology or life sciences
- Strong knowledge of GxP, GMP, GAMP 5, CSV and regulatory standards incl. FDA 21 CFR Part 11 and EU Annex 11
- Hands-on experience with SAP in regulated settings
- Experience with validation lifecycle documentation and audit support
- Strong analytical, communication and stakeholder management skills
- English at C1 level

💡 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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