QA Officer Operations

Description

Summary: Manages quality aspects and projects within the area of responsibility and ensures GxP compliance and adherence to quality management systems. Highlights: 1. Supervision of production and testing activities, cGxP compliance 2. Supports GxP compliance and Novartis quality management systems 3. QC/QA experience in pharmaceutical industry/biotech ### **Summary** \~Manages quality aspects and projects within the area of responsibility. \~Ensures and supports overall GxP compliance and adherence to Novartis quality management systems. ### **About the Role** Major Accountabilities \~ Supervision of all production and testing activities, ensuring compliance with cGxP, including data integrity and eCompliance \~ Support for investigation of deviations \~ Review and approval of production, QC, AS, and T records \~ Review MBR \~ Support for operational improvement projects Qualified personnel – bulk messaging as registered \~ Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt \~ Distribution of samples for product launch (if applicable) Key Performance Indicators \~Manages quality aspects and projects within the area of responsibility. \~Ensures and supports overall GxP compliance and adherence to Novartis quality management systems. Work Experience \~QC/QA in pharmaceutical industry / biotech with environmental monitoring & cleanroom zones \~Functional depth \~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 expertise 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