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Quality Head / GDP Responsible Person
Zentiva GroupWarsaw, Masovia, Poland30+ days ago
Job descriptionWykształcenie wyższe - mgr farmacji z czynnym Prawem Wykonywania Zawodu, doświadczeniem w obszarze GxP, uprawnienia Osoby Wykwalifikowanej w obszarze GMP będą dodatkowym atutem Bardzo dobra znajomość Prawa Farmaceutycznego, regulacji lokalnych i EU, dobrych praktyk GxP, umiejętność tworzenia procedur i map procesów, decyzyjność i umiejętność zarządzania ryzykiem Ekspert w zakresie systemów zapewnienia jakości Doświadczenie w prowadzeniu i procesowaniu audytów wewnętrznych i zewnętrznych Znajomość języka angielskiego
Zakres obowiązków :
- Pełnienie funkcji Osoby Odpowiedzialnej i odpowiedzialność za spełnienie wymagań DPD
- Zarządzanie dokumentacją GxP i nadzór nad obszarem GxP
- Udział, zarządzanie i nadzór nad Inspekcjami Władz Regulacyjnych
- Zarządzanie audytami jakościowymi
- Zarządzanie odchyleniami i CAPA
- Nadzór jakościowy i kwalifikacja lokalnych dostawców usług i podwykonawców z obszaru GxP
- Raportowanie i współpraca z HQ, funkcjami Quality
Wymagane kompetencje :
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Quality • Warsaw, Masovia, Poland
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