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Quality Assurance Manager Qualification

Ref: JN-092021-195672

Publié le 27 September 2021
Catégorie
Sciences de la vie

For our client in Visp we are looking for a Quality Assurance Manager Qualification.

Responsibilities:

  • Owns all quality related responsibilities for the commissioning and qualification (C&Q)) activities of dedicated new facilities, equipment and utilities related to the GMP manufacturing of biologics & APIs.
  • Representative of Quality in the CAPEX project organization in regards to qualification of facilities, utilities, equipment and systems (incl. computerized systems).
  • Reviews and releases of qualification documents and SOPs.
  • Be a Subject Matter Expert (SME) and provides guidance and recommendations to internal or external customers

Your profile

  • Bachelor, Master degree or PhD in biotechnology, chemistry, life science or related field
  • Significant experience in the GMP regulated pharmaceutical industry; preferable in a role within a Quality Unit
  • Strong background in cGMP
  • Broad knowledge in qualification of equipment, facilities, utilities (biopharmaceuticals & APIs) and related Guidelines (e.g. ASTM, ISPE, GAMP)
  • Experience in interaction with all kind of interfaces within the organization and with regulatory agencies (Swissmedic, FDA etc.)
  • Excellent verbal, written and interpersonal communications skills
  • Fluency in English, German would be an advantage