QA Operations Expert (f/m/d)
Novartis
Operations, Quality Assurance
Austria
Posted on Tuesday, October 31, 2023
About the Role
QA Operations Expert (w/m/d), Kundl, Österreich
As a QA Operations Expert you will be crucial in supporting our mission to supply more than 22 different high quality Biopharmaceutical Products to patients worldwide.
Your Responsibilities:
• Oversight of all production & testing activities, ensures compliance with cGxP, incl. data integrity and eCompliance
• Support and perform investigations in course of OOS and Deviation handling as QA
• Review and approval of production, QC, AS&T and MS&T records and SOPs
• Review of Master Batch Records
• Support OpEx improvement projects
• 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
As a QA Operations Expert you will be crucial in supporting our mission to supply more than 22 different high quality Biopharmaceutical Products to patients worldwide.
Your Responsibilities:
• Oversight of all production & testing activities, ensures compliance with cGxP, incl. data integrity and eCompliance
• Support and perform investigations in course of OOS and Deviation handling as QA
• Review and approval of production, QC, AS&T and MS&T records and SOPs
• Review of Master Batch Records
• Support OpEx improvement projects
• 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
