IT Validation Consultant (Life Sciences) | Wirtschaftsinformatiker (m/w/d)
gempex GmbH - THE GMP-EXPERT
Job Summary
This expert consulting role focuses on ensuring Computer System Validation (CSV) compliance within the highly regulated Life Sciences industry. The consultant will be responsible for implementing, optimizing, and maintaining quality assurance systems, specifically advising clients on CSV compliance for critical systems, including ERP, databases, and various automation platforms (MES, PLS, SPS). Core duties involve developing IT validation concepts based on GAMP 5 guidelines, preparing clients for official regulatory inspections, conducting internal and external training sessions, and actively participating in business development through client acquisition and relationship management. This position requires a minimum of 10 years of relevant IT/CSV consulting experience, excellent language skills in both German and English, and a willingness to travel, offering high autonomy and flexible work arrangements within a specialized consulting team.
Required Skills
Education
Completed degree in Informatics, Technical Informatics, or Business Informatics
Experience
- At least 10 years in IT/CSV consulting
- Professional experience in preparing and accompanying regulatory inspections
- Professional experience in IT validation concept creation
Languages
Additional
- Willingness to travel; High consultant competence and specialist expertise
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