Quality Control Specialist

Job description

Job Description Summary -Highly skilled and experienced laboratory professional who contributes by performing analytical release testing, investigational support, research support, and stability testing. Job Description 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. Skills Desired Continued 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