QA Deviations Specialist

hace 2 días


Insurgentes, México Novartis A tiempo completo

**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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