Junior CSV Specialist Pharma | (Junior) CSV Specialist Pharma (m/w/d)
FERCHAU GmbH Niederlassung Giessen
Job Summary
This role involves executing Computerized System Validation (CSV) and qualification projects for various systems like MES, LIMS, PLS, and automated production facilities within the pharmaceutical industry. The specialist will be responsible for creating system life-cycle documents such as validation plans, requirement specifications, risk analyses, and test plans. Key activities include conducting qualification measures (DQ, IQ, OQ, PQ), performing GAP analyses against pharmaceutical quality requirements, and advising clients on IT validation concepts. The position also supports GMP-specific audits, IT Change Management, and Test Management. This is an attractive opportunity for an ambitious professional looking to apply their technological expertise in exciting projects for reputable clients in Pharma and Life Science, benefiting from continuous professional development and a supportive work environment.
Required Skills
Education
Completed technical degree or completed technical training
Experience
- Professional experience in qualification/validation within the pharmaceutical industry
- Fundamental knowledge of qualification, validation, CSV, and GMP documentation
- Good knowledge of current European and American GMP regulations (Annex 11, 21 CFR Part 11, ISPE GAMP 5)
Languages
Additional
- Flexibility, willingness to travel, and strong service orientation
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