We have an open position for a quality Control specialist to focus on all activities concerning stabilities of assigned Biotech drug products.
* Managing the administration of stability programs in LIMS (i.e. timely and correct preparation of programs as well as their changes) taking into consideration regulatory stability requirements and information in the approved stability protocols · Ensuring samples are taken according to the relevant stability program, that samples are stored in the stability chambers promptly upon receipt and all samples and associated documentation are available the laboratories within the required timelines · Communicates with the manufacturing sites in case of any deviations related to the samples (e.g. number and condition of samples, etc.) · Provides expert advice to customers (e.g. regulatory affairs) on all stability related topics, such as deviations in product storage, transportation, etc. · Compiles and interprets stability data and provides scientifically sound conclusions to support assignment and monitoring of product shelf life, storage conditions, packaging and transport categories. · As part of the preparation of stability reports monitors stability data and communicates any adverse trends to management and study sponsor. · Timely prepares and reviews stability protocols and reports (TechOps), taking into account current regulatory requirements, requests from Health Authorities.
Languages German and English is required
Michael Bailey International is acting as an Employment Business in relation to this vacancy.