China Job Openings
Novartis
QA Operations Specialist
FULL TIME
November 18, 2024
Summary
Sistemi kakovosti/ procesi, vključno z dokumentacijo, meritve in spremljanjem ukrepov.
~Podpira vzpostavitev operativnih procesov kakovosti.
Izvaja rutinske Gx P skladnosti/ operativne dejavnosti v skladu s Novartis standardi kakovosti. Podpira kakovostne projekte in pobude.
About the Role
~ Vzdržuje veljavne standardne operativne postopke( SOP), dokumentacijo, ki je skladna z Gx P, in evidence v sistemu za upravljanje kakovosti Novartis.
~ Zagotavlja celovitost vseh zapisov in podatkov sistema kakovosti, kot je ustrezno, in sodelovanje lastne ekipe z drugimi funkcijami in oddelki.
~ Zagotavlja ustrezno raven izobrazbe, znanje Gx P.
~ Posodablja in vzdržuje ustrezne informacije v elektronskih sistemih (npr. Nadzor sprememb, dokumentacija, usposabljanje).
~ Spremljanje in spremljanje npr.
~ Podpira revizije kakovosti in inšpekcijski nadzor zdravstvenega organa.
~ 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
~Podpira vse dejavnosti Gx P v oddelku za kakovost.
Sistemi kakovosti/ procesi, vključno z dokumentacijo, meritve in spremljanjem ukrepov.
~Podpira vzpostavitev operativnih procesov kakovosti.
Izvaja rutinske Gx P skladnosti/ operativne dejavnosti v skladu s Novartis standardi kakovosti. Podpira kakovostne projekte in pobude.
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
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