Beschreibung
QUALITY ASSURANCE MANAGER QUALIFICATION (CAPEX)Location: Southern Switzerland
Duration: initially 6 months
My client is a global leader in life sciences. They are more than 15,000 employees in more than 100 locations around the world. The companies' greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, they let their people own their careers. And that's the kind of work my client wants to be part of.
In order to support the strategic growth investment of the company in Switzerland, I am looking for an experienced quality leader responsible for the equipment & facilities qualification aspects of the CAPEX projects portfolio.
The position is based in the south of Switzerland. The site is easily commutable from the Bernese Oberland (40 minutes by train from Thun) and 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.
Key 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
Key requirements:
- 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
People come to this company for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, they offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
Keywords: QUALITY ASSURANCE, QUALITY, QUALITY ASSURANCE MANAGER, QUALIFICATION, CAPEX, Subject Matter Expert, SME, equipment & facilities, equipment & facilities qualification, GMP, manufacturing, biologics, API, ASTM, ISPE, GAMP, pharmaceuticals, Switzerland, Thun
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.