QA Officer Operations

Description

Summary: Manage quality aspects and projects within the area of responsibility, ensuring GxP compliance and alignment with Novartis quality management systems. Highlights: 1. Oversight of all manufacturing and testing activities 2. Participation in exception investigations and OpEx reduction projects 3. Ensuring and supporting overall GxP compliance ### **Summary** \~ Manages quality aspects and projects within the area of responsibility. \~ Ensures and supports overall GxP compliance and alignment with Novartis quality management systems. ### **About the Role** Major Accountabilities \~ Oversees all manufacturing and testing activities, ensuring cGxP compliance, including data integrity and eCompliance \~ Participates in exception investigations \~ Reviews and approves production, quality control, AS, and T records \~ Analyzes CAPA \~ Participates in OpEx reduction projects Authorized Person\-executes batch release in accordance with registration data \~ Reports 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 overall GxP compliance and alignment with Novartis quality management systems. Work Experience \~ QC/QA in pharmaceutical/biotechnology industry with environmental monitoring and cleanroom oversight \~ Broad functional scope \~ Collaboration across organizational boundaries Skills \~ Technology scouting \~ QA (Quality Assurance) \~ GMP procedures \~ Quality standards \~ Quality Control (QC) testing \~ Working with ambiguity \~ Self-awareness \~ Continuous learning \~ Technology 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