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SAP S/4 HANA CSV Consultant (M/F/D)
Tasks:
Responsible for the validation of computerised systems (CSV), including managing change controls for SAP S/4 HANA and other regulated systems, platform/infrastructure and tool qualification.
Develop appropriate validation and/or qualification approaches for various SAP S/4HANA system functionalities and modules (including GxP, SOX/JSOX, and non-regulated areas).
Rollout of SAP S/4HANA in various regions and maintenance of global deployment, including change management.
Guiding and advising project teams on compliance assessments, requirements, test scripts, validation plans/protocols and reports.
Implementing CSV, QA and/or IT activities throughout the entire lifecycle, including initial implementation, modification and decommissioning.
Deep understanding and expert advice for method validation, process validation, equipment validation and instrument QC/testing in production facilities to ensure GMP compliance
Advising the audit team on communicating observations and recommendations, including assessing impacts and risk
Provide qualified CSV advice during the rollout of global solutions/systems and ensure that global standards/SOPs are effective, regulatory compliant and implementable.
Identification and implementation of strategic quality and business initiatives, including suitable remediation programmes, quality/compliance activities and relevant changes.
Qualification:
Bachelor’s degree in scientific or engineering discipline along with 10+ years of experience in the field of computer validation in the Life Sciences (Pharmaceutical, Medical Devices) and Healthcare industries is desirable.
10+ years’ experience in GxP / QA within FDA/EMA regulated environments GAMP 5 with risk-based CSV is required.
Must have extensive experience in validation and qualification of SAP S/4 HANA.
Experience in developing full validation documentation and testing protocols (IQ/OQ/PQ/UAT) within the various SDLC phases.
Ability to communicate effectively at all levels in the company in English.
Exceptional attention to detail, cross-checking, and verifying correctness of data.
Ability to effectively manage time to meet assigned deadlines and prioritize multiple work assignments.
Ability to work independently with minimal supervision.
Excellent Technical Writing skills in English.
Computer literate in Microsoft Word, Excel, PowerPoint, and working knowledge of Windows
Requirements:
Start: 01.03.2026
Duration: 6 months (extension possible)
Capacity: 5 days per week
Location: Metropolitan region Munich & remote
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