Quality Control Specialist

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 and personnel monitoring • Provide expert Support for site qualification and 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 Sandoz 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. 3-5years experience in Pharma/Manufacturing sector in analytical lab in. Collaborating across boundaries. A GMP environment/equivalent. 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.