Compliance & Quality System Manager

1 mese fa


Montà, Italia Innovative Medicines A tempo pieno

Summary
~Is alanlarinin Novartis Kalite El Kitabi ve Politikalari ile ilgili tüm GxP, yasal ve düzenleyici gerekliliklere uygunlugunu saglamak için ve iç denetimler, KPI'lar (Anahtar Performans Göstergeleri) ve KQI'ler (Anahtar Kalite Göstergeleri) yoluyla uygun maliyetli GxP Uyumlulugu ve/veya Denetim faaliyetlerini, operasyonlarini ve sistemlerini yönetmek
~ Dis ve kurumsal denetimlerin ve Saglik Otoritesi denetimlerinin hazirlanmasina ve yönetimine öncülük etmek.  
About the Role
Major Accountabilities
~ Kalite Yönetim Sisteminin Gözetimi ve Uygulanmasi
~ Olay yönetimi.
~ GxP Denetim ve denetim yönetimi
~ Site Düzenleyici gözetim (Reg-CMC kolaylastirma dahil)
~ Özel durum yönetimi
~ Tedarikçi Kalite yönetimi (yerel)
~ Nitelik ve dogrulama
~ Kalite Uyumu
~ Veri Bütünlügü ve eCompliance
~ Site KPI / KQI bakim / raporlama
~ Yerel ise alma sürecini baslatma ve yönlendirme
~ Hat sorumlulugu ve günlük geçis
~ Kursun OpEx Projeleri
~ Sapma, OOx, Sikayetlerin Incelenmesi
~ CAPA'lari tanimlayin ve uygulayin
~ Destek transfer projeleri ve validasyon çalismalari
~ Ekip ölçümlerini izleyin ve KQI/KPI'nin gereksinimleri karsilamasini saglayin
~ Metin ve tasarimi gözden geçirme ve onaylama
~ SEÇ olaylarinin raporlanmasi ve eylem takibi
~ Yeni ekipman devreye alma destegi (OQ, PQ)
~ Süreç ve ürünlerdeki iyilestirme alanlarini tanimlayin
~ Kaynak ve kapasite (kisi ve ekipman) planlama ve is yükü yönetimi
~ Uzman ekibe performans ve liderlik destegi
~ Uygun oldugu sekilde ekipman, kimyasal madde ve sarf malzemelerinin kullanilabilirligini saglamak
~ SÇP'nin gözden geçirilmesi ve gözden geçirilmesi
~ Yerel egitim gerçeklestirin ve egitim durumunu izleyin
~ Novartis ürünleriyle ilgili teknik sikayetlerin / olumsuz olaylarin / özel durum senaryolarinin alindiktan sonraki 24 saat içinde raporlenmesi
~ Pazarlama örneklerinin dagitimi (uygun oldugunda)
Key Performance Indicators
~Is alanlarinin Novartis Kalite El Kitabi ve Politikalari ile ilgili tüm GxP, yasal ve düzenleyici gerekliliklere uygunlugunu saglamak için ve iç denetimler, KPIlar (Anahtar Performans Göstergeleri) ve KQIler (Anahtar Kalite Göstergeleri) yoluyla uygun maliyetli GxP Uyumlulugu ve/veya Denetim faaliyetlerini, operasyonlarini ve sistemlerini yönetmek
~ Dis ve kurumsal denetimlerin ve Saglik Otoritesi denetimlerinin hazirlanmasina ve yönetimine öncülük etmek.  
Work Experience
~Fonksiyonel Kapsam
~Çalisanlara Liderlik Etmek
~Sinir ötesi is birligi
~Proje Yönetimi
Skills
~Büyük Olay Yönetimi
~Denetim
~Uygunluk Denetimleri
~Çalisan Performans Degerlendirmeleri
~Insan Kaynaklari Yönetimi
~QA (Kalite Güvencesi)
~Gmp Prosedürleri
~Saglik Otoriteleri
~Akilli Risk Alma
~Finans Zekasi
~Belirsizlikle Basa Çikmak
~Öz Farkindalik
~Sürekli Ögrenme
~Teknolojik Uzmanlik
~Karar Verme Becerileri
~Isbirligi / Takim Çalismasi
~Iletisim Becerileri
~Problem Çözme Becerileri
~Hedef Odaklilik
~Mantiksal Düsünme
~Liderlik
~Çeviklik
~Is Ortakligi
~Is Zekasi
~Paydas Yönetimi
~Problem Çözme Becerisi
Language
Ingilizce Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?
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