Quality compliance specialist
HELPInstitut Biochimique SA
Beschreibung: | Quality compliance specialist |
Stadt: | Collina d’Oro, Schweiz |
Firma: | - Firma bewerten |
Datum: | 2024-05-11 |
Beschäftigung: | >bis 100% |
Salär: | zu verhandeln CHF - 40 Std/Woche |
Arbeitsort: | Schweiz |
Tasks: Quality compliance specialist
Supporto al reparto R&D Pharmaceutical per implementazione e monitoraggio del Sistema di Qualità in accordo alle cGMP/GDP, alle ISO e alle normative vigenti per produzione e analisi di lotti di sperimentazioni cliniche (e.g. Annex 13, EU Clinical Trial Regulation e Regolamento Delegato). In particolare: Gestione documentale (revisione e approvazione di Procedure, Metodi Analitici, Batch Record, Report, Convalide, ecc); Gestione flussi di qualità quali Deviazioni, OOS/OOT, Reclami, Change control, CAPA, Design Control etc.
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