SAP GxP Consultant – Regulated Pharma

About the role

An experienced SAP GxP Consultant is sought to support and maintain SAP systems in a regulated pharmaceutical environment. The focus is 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, planned until the end of January.

Key responsibilities

• 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 (URS, FS, DS, IQ, OQ, PQ, risk assessments, traceability matrices)
• Support CSV activities in line with GAMP 5 and FDA/EU regulatory expectations
• Work 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 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

Required profile

• 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
• English C1

Nice to have

• Experience with S/4HANA migration or implementation projects
• Knowledge of data integrity and cybersecurity principles in regulated environments
• Experience in international or multicultural teams