Beschreibung
QA MANAGER QUALIFICATIONLocation: South of Switzerland, Thun area
Duration: until the end of the year
Start date: ASAP (latest 1st September)
In order to support the strategic growth investment of my client in the South of Switzerland, I am looking for an experienced quality leader, responsible for the equipment qualification.
Key responsibilities:
- Owns all quality related responsibilities for the commissioning and qualification (C&Q)) activities of dedicated new equipment, facilities and utilities related to the GMP manufacturing of biologics & APIs.
- Representative of Quality in the project organization in regards to qualification of facilities, utilities, equipment and 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
- More than 5 years of Experience in Biotech area
- At least 5 years of Experience as QA Qualification/Validation position
- Knowledge on USP / DSP and related Guidelines (e.g. ASTM, ISPE, GAMP)
- First experience with the PQ phase (performance qualification)
- Strong background in cGMP
- Experience in interaction with all kind of interfaces within the organization and with regulatory agencies (Swissmedic, FDA etc.) beneficial
- Excellent verbal, written and interpersonal communications skills
- Fluency in English, German and French would be an advantage
Keywords: QA Manager Qualification, equipment qualification, commissioning, C&Q, facilities, utilities, GMP, manufacturing, documents, SME, biotechnology, chemistry, life science, Pharmaceuticals, Biotech, QA, USP, DSP, Guidelines, cGMP, Schweiz, Switzerland, Thun
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.