Summary: Manage quality systems and support GxP activities, compliance, operational processes, and quality projects. Highlights: 1. QC/QA experience in the pharmaceutical/biotechnology industry 2. Supporting GxP activities within the Quality department 3. Management of quality systems and processes ### **Summary** \~Support all GxP activities within the Quality department. Manage quality systems/processes, including documentation, metrics, and action monitoring. \~Support the establishment of quality operational processes. Conduct regular GxP compliance/operational activities in accordance with Novartis quality standards. Support 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 integrity of all quality system records and data, and apply cross-functional and cross-departmental teamwork. \~Ensure adequate level of education and GxP knowledge. \~Update and maintain relevant electronic system information (e.g., change management, documentation, training). \~Follow-up and monitoring (e.g., CAPA, actions, metrics, quality plans). \~Support quality audits and health authority inspections. \~Report technical complaints/harmful events/special cases related to Novartis products within 24 hours of receipt. \~Distribution of marketing samples (where applicable) Key Performance Indicators \~Support all GxP activities within the Quality department. Manage quality systems/processes, including documentation, metrics, and action monitoring. \~Support the establishment of quality operational processes. Conduct regular GxP compliance/operational activities in accordance with Novartis quality standards. Support quality projects and initiatives. Work Experience \~QC/QA experience in the pharmaceutical/biotechnology industry (environmental monitoring, cleanroom operations) \~Broad functional scope \~Collaboration across boundaries Skills \~Technical intelligence \~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 Regular Shift Work No VIDEO