Job ID: 11875

Quality Assurance Specialist CSV

The position is based in Visp Switzerland, the site is easily commutable from the Bernese Oberland (40 minutes by train from Thun). Visp, also known as the sun center of Switzerland, is located in the Swiss Alps close to Zermatt, Saas Fee, Verbier and Cran-Montana – a beautiful area to go skiing in the winter or enjoying great views during hiking and biking tours in the summer.


Project Consulting

Ihre Aufgaben.

  • Owning all quality related responsibilities for the Computerized System Validation (CSV): activities of dedicated new facilities, equipment and utilities related to the GMP manufacturing of biologics & APIs

  • Representing the quality department in the CAPEX project organization in regards to CSV

  • Reviewing and releasing CSV documents and SOPs

  • Being a Subject Matter Expert (SME) and providing guidance and recommendations to internal or external customers

Ihr Anforderungsprofil.

  • Bachelor or Master Degree in Biotechnology, Chemistry, Life Science or related field

  • Significant experience in the GMP regulated pharmaceutical industry; preferable in a role within a Quality Unit

  • Broad knowledge in CSV, Data Integrity  and related guidelines (21 CFR Part 11, EU GMP Annex 11, GAMP5 and the underlying principles of each)

  • Experience in interaction with all kind of interfaces within the organization and with regulatory agencies (Swissmedic, FDA etc.)

  • Working knowledge within electronic document management systems

  • Fluency in English, German would be an advantage


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