We are currently looking for an experienced Computer System Validation (CSV) Consultant (m/f/d) to join our team under and support a leading pharmaceutical client on-site in Schaffhausen, Switzerland.
This is an exciting opportunity to work in a highly regulated GxP environment within an international pharmaceutical setting while benefiting from the stability of a German permanent position.
Your Responsibilities
* Plan and execute CSV activities in accordance with GAMP 5
* Create and review validation documentation (URS, FS, DS, IQ, OQ, PQ)
* Perform risk assessments and impact analyses
* Ensure compliance with EU GMP Annex 11 and 21 CFR Part 11
* Support system implementations, upgrades, and change controls
* Collaborate with QA, IT, engineering, and business stakeholders
* Support internal and external audits and inspections
Your Profile
* Degree in Life Sciences, Computer Science, Engineering, or similar
* Minimum 3 years of experience in CSV within the pharmaceutical industry
* Strong knowledge of GAMP 5, Annex 11, and 21 CFR Part 11
* Experience with systems such as SAP, LIMS, MES, or similar
* Fluent in German and English
* Structured, solution-oriented, and strong communicator
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