Job Summary: This position supports all GxP activities within the Quality function, manages quality systems and processes, and executes compliance/operational activities in accordance with Novartis quality standards. Key Responsibilities: 1. Maintain applicable Standard Operating Procedures (SOPs) and documents within the Novartis Quality Management System 2. Ensure the integrity of all quality system records and data 3. Support quality audits and health authority inspections ### **Summary** * Support all GxP activities within the Quality function. Manage quality systems/processes, including documentation, metrics, and action tracking. * Support the establishment of high-quality operational processes. Execute routine GxP compliance/operational activities in accordance with Novartis quality standards. Support high-quality projects and initiatives. ### **About the Role** Major Accountabilities \~ Maintain applicable Standard Operating Procedures (SOPs), GxP-compliant documents, and records within the Novartis Quality Management System. \~ Ensure the integrity of all quality system records and data, as applicable, and collaborate with own team and other functions/departments. \~ Ensure adequate education level and GxP knowledge. \~ Update and maintain relevant information in electronic systems (e.g., change control, documentation, training). \~ Track and monitor (e.g., CAPA, operations, metrics, quality plans). \~ Support quality audits and health authority inspections. \~ Report technical complaints/adverse events/special circumstances related to Novartis products within 24 hours of receipt. \~ Distribution of marketing samples (as applicable) Key Performance Indicators * Support all GxP activities within the Quality function. Manage quality systems/processes, including documentation, metrics, and action tracking. * Support the establishment of high-quality operational processes. Execute routine GxP compliance/operational activities in accordance with Novartis quality standards. Support high-quality projects and initiatives. Work Experience \~ QC/QA experience in environmental monitoring and cleanroom operations within the pharmaceutical/biotechnology industry \~ Breadth across functions \~ Cross-functional collaboration Skills \~ Technical intelligence \~ QA (Quality Assurance) \~ GMP procedures \~ Quality standards \~ Quality Control (QC) testing \~ Handling 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 Permanent Shift Work No VIDEO