Digital Quality Control Specialist

hace 7 días


Insurgentes, México Novartis A tiempo completo

**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 Role**:**Major 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 registration**Minimum 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.DivisionOperationsBusiness UnitInnovative MedicinesLocationMexicoSiteINSURGENTESCompany / Legal EntityMX06 (FCRS = MX006) Novartis Farmacéutica S.A. de C.V.Functional AreaQualityJob TypeFull timeEmployment TypeRegularShift WorkNo**Accessibility and accommodation**:Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.



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