Junior CSV Specialist Pharma | (Junior) CSV Specialist Pharma (m/w/d)
FERCHAU GmbH Niederlassung Giessen
Job Summary
This role is for a proactive and ambitious Junior CSV Specialist in the pharmaceutical and life sciences sector. The successful candidate will be responsible for executing Computer System Validation (CSV) and qualification projects for various systems like MES, LIMS, PLS, and automated production facilities. Key tasks include creating system life cycle documents such as validation and qualification plans, requirement specifications, risk analyses, and test plans. The role also involves conducting qualification measures (DQ, IQ, OQ, PQ), performing GAP analyses against pharmaceutical quality standards, and advising clients on IT validation concepts. This position offers an opportunity to contribute to digital transformation, work on diverse projects for innovative companies, and benefit from continuous professional development.
Required Skills
Education
Completed technical degree or completed technical training
Experience
- Professional experience in qualification/validation within the pharmaceutical industry
- Thorough 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
- Travel readiness
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