Key Responsibilities:
1. Holds all quality related responsibilities for daily qualification activities on technical facilities, equipment and systems
2. Supports the development, reviews and releases qualification documents
3. Approves applicable qualification documents
4. Assesses and approves change requests with regard to their relevance to the qualified state condition and ensures this supports and approves quality risk analysis (e.g. GMP-FMEA)
5. Ensures that deviations are appropriately investigated and addressed in deviation reports processed in deviation reports
6. QA activities follow legislation, authority and customer expectations
7. Informs the Group Manager QA Qualification about relevant developments and trend
8. Actively supports the formulation and further development of qualification strategies and continues to training accordingly
9. Supports internal audits in accordance with the internal audit plan, at customer audits and official inspections as QA representative (SME)
Key Requirements:
10. Experience in biotechnology or pharmaceutical environment
11. Experience as QA Qualification
12. Knowledge on FAT/SAT/IQ/OQ/PQ
13. You are proactive, with good communication skills and are able to work in a multidisciplinary team towards a common goal
14. You are fluent in English (spoken and written)
15. max. 40% homeoffice possible
For further information about this position, please apply with your CV
*Please note, only those with the right to work in Switzerland can apply!