Novartis

QA Operations Specialist

FULL TIME

November 18, 2024

Summary
~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.
About the Role
Major Accountabilities

~ 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
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? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Division
Operations
Business Unit
Innovative Medicines
Location
China
Site
Changping County (Beijing)
Company / Legal Entity
CN06 (FCRS = CN006) Beijing Novartis Pharma Co., Ltd
Functional Area
Quality
Job Type
Full time
Employment Type
Redni sodelavec
Shift Work
No
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