Zurich, Switzerland
- Develope, implement and continuously improve all aspects of the Quality Management System of Celgene Chemicals according to EU GMP PART II (API) and 21 CFR part 210/211 - Deputy of the “Fachtechnisch verantwortliche Person (FvP)”/QP according to Swissmedic regulations
Responsible for the correct and timely testing of Bioburden, Sterility and Endotoxin of parental drug products (commercial and development).
- Lead the Quality Management Team including QA, QC and AS&T. - Develope, implement and continuously improve the Quality Management System according to ISO 9001, ISO 13485, 21 CFR 820 - Process owner for CAPA, Risk Management, Change Control and Audits (internal/external)
- Sustain and maintain a Quality Management System according to ISO 9001, ISO 13485, 21 CFR 820, EU-GMP-Guide