Summary: Supports GxP activities in the Quality department, administers quality systems, and supports the development of quality operational processes, performing routine GxP compliance activities. Highlights: 1. Supports all GxP activities in the Quality department 2. Administers quality systems/processes 3. Supports the development of quality operational processes ### **Summary** \~Supports all GxP activities in the Quality department. Administers quality systems/processes, including documentation, metrics, and action tracking. \~ Supports the development of quality operational processes. Performs routine operational and GxP compliance activities according to 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 the Novartis Quality Management System. \~ Ensures integrity of all quality system records and data, application, and collaboration of own team with other functions and departments. \~ Ensures adequate level of training and GxP knowledge. \~ Updates and maintains relevant information in electronic systems (e.g., change control, documentation, training). \~ Follow-up and monitoring of CAPA, 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 (if applicable) Key Performance Indicators \~Supports all GxP activities in the Quality department. Administers quality systems/processes, including documentation, metrics, and action tracking. \~ Supports the development of quality operational processes. Performs routine operational and GxP compliance activities according to Novartis quality standards. Supports quality projects and initiatives. Work Experience \~QC/QA in pharmaceutical/biotechnology industry with environmental monitoring and cleanroom areas \~Functional extension \~Intra-company collaboration Skills \~Technological Intelligence \~QA (Quality Assurance) \~GMP Procedures \~Quality Standards \~Quality Control (QC) Testing \~Managing Ambiguity \~Self-awareness \~Continuous Learning \~Technological Competence 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