-Highly skilled and experienced laboratory professional who contributes by performing analytical release testing, investigational support, research support, and stability testing. About the Role Major accountabilities: CAPA definition, KPI trending, and ensuring all activities comply with cGxP, including data integrity review and approval of analytical data/tests (analytical release). Stability testing (Projects) – protocol preparation, evaluation, and report preparation. Reporting (Stability plan preparation, trend analysis, evaluation) and performance of Stability studies, protocols, and comparative reports for supplier qualification. Review and approval of analytical tests (analytical release). Microbiological QC – perform microbiological testing of materials and utilities, environmental, and personnel monitoring. Provide expert support for site qualification and validation activities. Maintain and calibrate equipment, including plan preparation. Support in supplier qualification. Trending and analysis of KPI/KQI. Support sample planning and sampling execution. Reporting of 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: The relevant KPIs defined in the Quality Control areas apply, e.g., analytical lead times and timely and GMP-compliant analysis & documentation of the results. Error rate: Number of OOS (analysis errors) related to the number of analyzes and no complaints about official inspections. Individual performance is assessed using the PMP performance dialog together with the manager. Functional breadth. 3-5 years experience in Pharma/Manufacturing sector in analytical lab. Skills: Dealing with ambiguity. Decision-making skills. GxP. Industry standards. Laboratory equipment. Laboratory excellence. Quality control (QC) testing. Quality control sampling. Technological expertise. Total quality management. Languages: 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 to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up. IT58 (FCRS IT058) Advanced Accelerator Applications Italy Srl Functional Area: Quality Job Type: Full time Employment Type: Regular Shift Work: No Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. J-18808-Ljbffr