At the moment, we are collaborating with a global lead Biopharma CMO in Switzerland to find a Quality Engineer.
- Hold all quality related responsibilities for daily qualification activities on technical facilities, equipment and systems
- Facilitate coordination meetings between different departments related to Engineering Change Notifications, Incidents and Punch Items to ensure a compliant handling of these documents.
- Assess and approve change requests with regard to their relevance to the qualified state condition.
- Assess and approve test incidents.
- Approve applicable qualification documents
- Actively support the formulation and further development of qualification strategies, with special focus on Engineering changes and Incidents.
- Inform the Group Manager QA Qualification about relevant developments and trends
- Support internal audits in accordance with the internal audit plan, at customer audits and official inspections as QA representative (SME)
- Experience in biotechnology or pharmaceutical environment
- Experience in QA Qualification and Engineering
- Knowledge on Change Management, Incident Management and Punch Item Management
- You are proactive, with good communication skills and are able to work in a multidisciplinary team towards a common goal.
- Fluency in English (spoken and written)
- Experience in Risk Analysis
- German speaking
- Knowledge of Kneat
Interviews and offers can happen this week!
If you’re interested in the above description, please apply with your CV today. For further information, please contact Daria Finikova at +31 (0)20 20 44 502 or by email at firstname.lastname@example.org