About this role
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