QA Consultant - Novartis site Cambé
Novartis
Quality Assurance
Brazil
Posted on Friday, May 26, 2023
28,000 associates of more than 100 nationalities deliver high quality and affordable medicine on time, every time, safely and efficiently.
Your responsibilities include, but are not limited to:
• Oversight of all production & testing activities, ensures compliance with cGxP, incl. data integrity and eCompliance
• Support exception investigations
• Review and approval of production, QC, and AS & 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
• Responsible for managing quality aspects within area of responsibility and to ensure that the operational business is in compliance with cGMP (Current Good Manufacturing Practices), the Quality Assurance Agreement, regulatory requirements & the Novartis Quality Manual and is conducted according to the relevant Standard Operating Procedures
Your responsibilities include, but are not limited to:
• Oversight of all production & testing activities, ensures compliance with cGxP, incl. data integrity and eCompliance
• Support exception investigations
• Review and approval of production, QC, and AS & 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
• Responsible for managing quality aspects within area of responsibility and to ensure that the operational business is in compliance with cGMP (Current Good Manufacturing Practices), the Quality Assurance Agreement, regulatory requirements & the Novartis Quality Manual and is conducted according to the relevant Standard Operating Procedures
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