Stability Supervisor
CurrentCoordination of all Stability Studies of Validation batches (ΕU & US products) supervising RND chemist and technicians (team of 8 people). Evaluate Stability studies results for new products dossiers (EU & US) and preparation of stability protocols (EU & US). Design and implementation in the preparation of stability tables and review stability results in parallel with originator analysis results. Stability requirements and clarifications requested from DLs or clients (EU & US). Retested CoA’s of stability products. Specific analytical work requested from DLs or clients, preparation of reports, CoA’s for special client’s request. Issue product protocols according to clients’ specifications and handling Change Controls / Deviations, DIRs, Risk assessment. Preparation of Annual Stability Budget and Cost of new products stability study. Daily, Weekly, Monthly and Yearly planning of stability analysis and Monthly / weekly / annual report. Collaboration with Regulatory affairs Quality assurance and CMO and coordinated with Regulatory affairs department for ANDA, NDA and EU submissions. Ability to deliver high quality work, in a timely manner and under specific deadlines.
