One of the largest global Biotech companies is looking to continue their rapid growth of their site in central Switzerland.
We are currently seeking a QA Qualification Manager with experience within the Pharmaceutical Industry.
The successful candidate will be responsible for the equipment & facilities qualification aspects of the CAPEX projects portfolio.
Key Responsibilities:
- Own 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)
- Review and release 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 2 years of Experience as QA Qualification/Validation OR 5 years in CQV position
- Knowledge on Drug Product (Filling Line, Isolator, depyro tunnel, Washing machine, autoclave) and related Guidelines (e.g. ASTM, ISPE, GAMP)
- Strong 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.)
- Excellent verbal, written and interpersonal communications skills
- Fluency in English, German would be an advantage
