Die Stelle
0401Perform bioanalytical release and stability testing in compliance with cGxP and data integrity requirements.
02Prepare, evaluate, and report on project-related protocols, plans, trend analyses, and testing activities.
03Implement new product testing into the routine laboratory and support method development and validation activities.
04Manage analytical weak points, perform complex troubleshooting, and support continuous improvement of laboratory workflows.
05Review analytical data and tests, including analytical release activities, to ensure accuracy, quality, and compliance.
06Handle OOx results and deviations, define CAPAs, and contribute to effective investigation processes.
07Maintain and calibrate laboratory equipment, including preparation of maintenance and calibration plans.
08Act as SPoC or SME for bioanalytics initiatives and contribute to relevant documentation workflows and technical authoring.
09Support sample planning, sampling execution, supplier qualification, and KPI/KQI trending and analysis.
10Follow all HSE guidelines, proactively identify and report potential risks, propose solutions, and participate in required trainings.
