Quality Assurance Analyst

1 semana atrás


Santo Amaro, Brasil Novartis Tempo inteiro

Summary-Manages Quality aspects and projects within area of responsibility.
-Ensures and supports overall GxP conformity and Compliance with the Novartis Quality Management Systems.About the RoleMajor accountabilities:Oversight of all production and testing activities, ensures compliance with cGxP, incl.
data integrity and eCompliance -Support exception investigations -Review and approval of production, QC, and AS and T records -MBR review -Support OpEx improvement projects Qualified Person – Executes batch release in compliance with registration -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)Key performance indicators:On-time and GMP-compliant release of dosage forms -No complaints about inspections by authorities in your own area of responsibility without these being noticed and communicated beforehand -Successfully support continuous improvement projects -Executes batch release in compliance with registrationMinimum Requirements:Work Experience:Functional Breadth.QC/ QA in pharmaceutical ind.
/ biotech with environmental monitoring &.
Collaborating across boundaries.cleanliness zones.Skills:Continuous Learning.Dealing With Ambiguity.Gmp Procedures.Qa (Quality Assurance).
Quality Control (Qc) Testing.Quality Standards.Self Awareness.Technological Expertise.Technological Intelligence.Languages :English.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?
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: Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: DivisionOperationsBusiness UnitInnovative MedicinesLocationBrazilSiteSanto AmaroCompany / Legal EntityBR03 (FCRS = BR003) NOVARTIS BIOCIENCIAS S.AFunctional AreaQualityJob TypeFull timeEmployment TypeRegularShift WorkNo


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