✨ AI Summary
The Professional Stability Analyst will be responsible for preparing stability study files for submission to regulatory authorities (EDA) and reviewing stability analyses performed by other analysts. Key duties include managing laboratory equipment maintenance, calibration, and troubleshooting, closely monitoring analytical processes, distributing tasks based on priorities, and performing chemical and physical analyses. The role also involves conducting instrumental analysis using various sophisticated equipment (HPLC, GC, UV-Vis, IR, AAS) after training, preparing reagents, documenting results, and reporting any deviations or out-of-specification findings.
Requirements
Bachelor of Pharmacy or Science.+5 years of experience in a similar position in reputable pharmaceutical companies.Problem-solving and analytical skills.Attention to details.Good Communication skills.Good command of English.Professional using Microsoft Office.
Description
Prepare stability study files to be submitted to EDA.Reviewing of stability analysis performed by stability analysts.Follow up Laboratory devises (Maintenance, Calibration and Troubleshooting plan)Close monitoring of analysis and solving analysis troubleshoots.Close monitoring and distributing analytical process according to priorities.Chemical and Physical analysis according to method and specification for after having the necessary training.Intermediate check for equipment.Performing instrumental analysis using HPLC, Gas chromatographs, UV - Vis Spectrophotometer, IR spectrophotometer and Atomic Absorption Spectrophotometer and other minor analytical equipment after having the necessary Training.Preparation of chemical reagents and other required volumetric solution as directed.Documentation of analytical results according to the predetermined procedure.Reporting deviation, suspect results, out of specification results and any other Required reports