Summary-Highly skilled & 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, incl. data integrity review and approval of analytical data / tests (analytical release) Stability -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 & personnel monitoring -Provide expert Support for site qualification & validation activities -Maintain and calibrate equipment incl. 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 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 analyzes -No complaints about official inspections. Individual performance is assessed using the PMP performance dialog together with the manager Minimum Requirements: Work Experience: Functional Breadth. Collaborating across boundaries. 3-5years experience in Pharma/Manufacturing sector in analytical lab in. a GMP environment/equivalent. Skills: Quality Control Sampling. Laboratory equipment. Quality Control (QC) Testing. Laboratory Excellence. Innovative & Analytical Technologies. Knowledge of TQM and related industry GxP standards and processes. Giving feedback. Managing resources. Quality decision making. Risk Management. Knowledge of IT Applications & tools. Knowledge of information management and security. 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. 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:
