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