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 registration.Functional Breadth.QC/QA in pharmaceutical ind./biotech with environmental monitoring.Skills: Dealing With Ambiguity.GMP Procedures.QA (Quality Assurance).Quality Control (QC) Testing.Quality Standards.Technological Expertise.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?
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Functional Area: Quality
Job Type: Full time
Employment Type: Regular
Shift Work: No
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