Job Summary: This role supports all GxP activities in the Quality department, manages Quality Systems/Processes, and ensures compliance with Novartis standards. Key Highlights: 1. Supports all GxP activities in the Quality department. 2. Manages Quality Systems/Processes and tracks actions. 3. Ensures the integrity of all records and data within Quality Systems. ### **Summary** \~Supports all GxP activities in the Quality department. Manages Quality Systems/Processes including documentation, metrics, and action tracking. \~Supports the establishment of Quality operational processes. Performs routine GxP/compliance and operational activities in accordance with Novartis quality standards. Supports Quality projects and initiatives. ### **About the Role** Major Accountabilities \~ Maintains applicable Standard Operating Procedures (SOPs), documentation, and GxP-compliant records within the Novartis Quality Management System. \~ Ensures the integrity of all records and data within Quality Systems, as appropriate, and collaborates with own team and other functions/departments. \~ Ensures an appropriate level of education and GxP knowledge. \~ Updates and maintains relevant information in electronic systems (e.g., Change Control, Documentation, Training). \~ Tracks and follows up on, for example, CAPAs, actions, metrics, quality plan). \~ Supports quality audits and health authority inspections. \~ Reports technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt. \~ Distribution of marketing samples (where applicable) Key Performance Indicators \~Supports all GxP activities in the Quality department. Manages Quality Systems/Processes including documentation, metrics, and action tracking. \~Supports the establishment of Quality operational processes. Performs routine GxP/compliance and operational activities in accordance with Novartis quality standards. Supports Quality projects and initiatives. Work Experience \~QC/QA in pharmaceutical/biotechnology industry with environmental monitoring and cleanroom operations \~Functional breadth \~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 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 Regular Shift Work No VIDEO