QA Officer Operations

Description

Job Summary: This role manages Quality and project-related aspects, ensuring overall GxP compliance and adherence to Novartis’ quality management systems. Key Highlights: 1. Supervision of production and testing activities to ensure cGxP compliance. 2. Review and approval of production, quality control, and AS&T records. 3. Support for OpEx improvement projects and batch release management. ### **Summary** \~Manages Quality and project-related aspects within the area of responsibility. \~Ensures and supports overall GxP compliance and adherence to Novartis’ quality management systems. ### **About the Role** Major Accountabilities \~Supervises all production and testing activities to ensure cGxP compliance, including data integrity and electronic compliance. \~Supports investigation of exceptions. \~Reviews and approves production, quality control, and AS&T records. \~Reviews MBRs. \~Supports OpEx improvement projects. Qualified Person\-Executes batch release in compliance with regulatory registration. \~Notifies technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt. \~Distribution of commercial samples (where applicable). Key Performance Indicators \~Manages Quality and project-related aspects within the area of responsibility. \~Ensures and supports overall GxP compliance and adherence to Novartis’ quality management systems. Work Experience \~QC/QA experience in pharmaceutical/biotechnology industry with environmental monitoring and cleanroom operations. \~Broad functional scope. \~International collaboration. Skills \~Technological Intelligence \~QA (Quality Assurance) \~GMP Procedures \~Quality Standards \~Quality Control (QC) Testing \~Dealing with Ambiguity \~Self-awareness \~Continuous Learning \~Technological Experience 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