Summary 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: OOx/Deviation handling. CAPA definition. KPI trending. Ensure all activities in compliance with cGxP, including data integrity review and approval of analytical data/tests (analytical release). Stability Testing: Stability testing (Projects) – protocol preparation, evaluation, report preparation. Reporting (Stability plan preparation, trend analysis, evaluation). 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. Support Responsibilities: 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 that are defined in the Quality Control areas apply: e.g. analytical lead times - Timely and GMP-compliant analysis & documentation of the results. Error rate: Number of OOS (analysis errors) related to the number of analyses - No complaints about official inspections. Individual performance is assessed using the PMP performance dialog together with the manager. Minimum Requirements: Work Experience: Functional breadth. 3-5 years experience in Pharma/Manufacturing sector in analytical lab in a GMP environment/equivalent. Collaborating across boundaries. Skills: Continuous Learning. Dealing With Ambiguity. Decision Making Skills. GxP. Industry Standards. Laboratory Equipment. Laboratory Excellence. Quality Control (QC) Testing. Quality Control Sampling. Self Awareness. Technological Expertise. Total Quality Management. Languages: 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.
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Business Unit: Innovative Medicines
Location: Italy
Site: Ivrea
Company / Legal Entity: IT58 (FCRS = IT058) AAA 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.
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