A leading Biopharmaceutical manufacturer is looking for experienced QA Managers to join their brand new site in southern Switzerland. This division is working on a novel vaccine against coronavirus.
Key responsibilities of the QA Manager include:
Ensure the quality oversight of a new facility and drug substances produced therein
Be involved in transfers of manufacturing processes. Maintain contact with customers, facilitate discussions between customers and internal teams such as MSAT (Manufacturing Science & Technology), Manufacturing, Engineering and Quality Control
Review and approve Discrepancy Records and Change Requests, manage the process for notifying the customer about discrepancies / change requests and assuring the customer's feedback and relevant comments are addressed internally
Review and approve SOPs and project related documents; support and approve quality risk analysis (e.g. FMEA). Write or revise SOPs in your area of expertise and act as Owner of such documents
Be involved in customer audits as well as in regulatory inspections and support all activities to ensure inspection readiness of the department
Key requirements of the QA Manager include:
- Bachelor in Biotechnology, Biology, Chemistry or other natural science
- Substantial experience in the area of biopharmaceutical manufacturing
- Broad knowledge of biotechnological manufacturing processes (especially microbiological biotech processes) as well as in cGMP
- Good communication skills and interaction with all kind of interfaces within the organization and with regulatory agencies
- Strong team orientation and solution-oriented working approach
- Structured, focused and well-organized working attitude
- Fluency in English, German would be an advantage