QA Officer Operations

Description

Summary: Manages quality aspects and projects, and ensures GxP compliance as well as adherence to Novartis quality management systems. Highlights: 1. Monitoring of production and testing activities 2. Supporting investigation of exceptions 3. Performing batch release in accordance with registration ### **Summary** \~Manages quality aspects and projects within the area of responsibility. \~Ensures and supports GxP compliance and adherence to Novartis quality management systems. ### **About the Role** Major Accountabilities \~ Monitoring all production and testing activities, ensuring compliance with cGxP, including data integrity and eCompliance \~ Supporting investigation of exceptions \~ Reviewing and approving production, QC, AS, and T records \~ MBR outlook \~ Supporting OpEx improvement projects Qualified Person \- Performing batch release in accordance with registration \~ Reporting technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt \~ Distribution of marketing samples (if applicable) Key Performance Indicators \~Manages quality aspects and projects within the area of responsibility. \~Ensures and supports GxP compliance and adherence to Novartis quality management systems. Work Experience \~QC/QA in pharmaceutical industry/biotechnology with environmental monitoring and cleanroom zones \~Functional breadth \~Cross-border collaboration Skills \~Technological intelligence \~QA (Quality Assurance) \~GMP procedures \~Quality standards \~Quality control (QC) testing \~Dealing with ambiguity \~Self-awareness \~Continuous learning \~Technological know-how Language 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? https://www.novartis.com/about/strategy/people\-and\-culture **Benefits and Rewards:** Learn about all the ways we’ll help you thrive personally and professionally. Read our handbook (PDF 30 MB) Division Operations Business Unit Production / Manufacturing Location Spain Site Zaragoza Company / Legal Entity ES45 (FCRS \= ES045\) Advanced Accelerator Applications Iberica S.L.U. Functional Area Quality Job Type Full time Employment Type Regular Shift Work No VIDEO