Summary: This position supports all GxP activities within the Quality department by administering quality systems and processes and ensuring GxP compliance. Highlights: 1. Supports GxP activities within the Quality department. 2. Administers quality systems and processes. 3. Ensures GxP compliance and adherence to Novartis quality standards. ### **Summary** \~ Manages all GxP activities within the Quality department. Administers quality systems/processes, including documentation, actions, and follow-up. \~ Supports implementation of operational quality processes. Performs routine operational and GxP compliance activities in accordance with Novartis quality standards. Supports quality projects and initiatives. ### **About the Role** Major Accountabilities \~ Maintains applicable Standard Operating Procedures (SOPs), GxP-compliant documentation, and records within Novartis’ Quality Management System. \~ Ensures integrity of all quality system records and data, where applicable, and collaborates across own team with other functions and departments. \~ Ensures adequate education and GxP knowledge. \~ Updates and maintains relevant information in electronic systems (e.g., change control, documentation, training). \~ Tracks and follows up on CAPAs, actions, measures, quality plans, etc. \~ Supports quality audits and regulatory authority inspections. \~ 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 all GxP activities within the Quality department. Administers quality systems/processes, including documentation, actions, and follow-up. \~ Supports implementation of operational quality processes. Performs routine operational and GxP compliance activities in accordance with Novartis quality standards. Supports quality projects and initiatives. Work Experience \~ QC/QA in pharmaceutical/biotech industry with environmental monitoring and cleanroom areas \~ Functional scope \~ Cross-border collaboration Skills \~ Technology awareness \~ QA (Quality Assurance) \~ GMP procedures \~ Quality standards \~ Quality control (QC) testing \~ Dealing with ambiguity \~ Self-awareness \~ Continuous learning \~ Technical 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 Quality Location Spain Site Zaragoza Company / Legal Entity ES45 (FCRS \= ES045\) AAA Ibérica S.L.U. Functional Area Quality Job Type Full time Employment Type CDI Shift Work No VIDEO