QA Deviations Specialist
hace 2 días
**Summary**:
~Upravlja vidike kakovosti in projekte znotraj področja odgovornosti.
~Zagotavlja in podpira splošno skladnost GxP in skladnost z Novartisovimi sistemi vodenja kakovosti.
**About the Role**:
Major Accountabilities
~ Nadzor nad vsemi proizvodnimi in testnimi aktivnostmi, zagotavlja skladnost s cGxP, vključno s celovitostjo podatkov in e-skladnostjo
~ Podpora preiskavam izjem
~ Pregled in odobritev proizvodnih zapisov, evidenc QC ter AS in T
~ MBR pregled
~ Podpora projektom za izboljšanje OpEx
Kvalificirana oseba - izvaja sprostitev serije skladno z registracijo
~ Poročanje o tehničnih pritožbah / neželenih dogodkih / scenarijih posebnih primerov, povezanih z Novartis izdelki v roku 24 ur po prejemu
~ Distribucija vzorcev trženja (kjer je primerno)
Key Performance Indicators
~Upravlja vidike kakovosti in projekte znotraj področja odgovornosti.
~Zagotavlja in podpira splošno skladnost GxP in skladnost z Novartisovimi sistemi vodenja kakovosti.
Work Experience
~QC/QA v farmacevtski industriji/biotehnologiji z nadzorom okolja in čistilnimi conami
~Funkcionalna širina
~Sodelovanje prek meja
**Skills**:
~Tehnološka inteligenca
~Qa (zagotavljanje kakovosti)
~Postopki dobre proizvodne prakse
~Standardi kakovosti
~Testiranje nadzora kakovosti (Qc)
~Odpravljanje dvoumnosti
~Samozavedanje
~Stalno učenje
~Tehnološko strokovno znanje
Language
Angleščina
Division
Operations
Business Unit
Innovative Medicines
Location
Mexico
Site
INSURGENTES
Company / Legal Entity
MX06 (FCRS = MX006) Novartis Farmacéutica S.A. de C.V.
Functional Area
Quality
Job Type
Full time
Employment Type
Redni sodelavec
Shift Work
No
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