The position requires a Bachelors degree, or foreign degree equivalent, in physical or biological sciences or engineering and two 2 years of quality control andor regulatory experience in a cGMPFDA regulated environment in any occupational title. The position requires two 2 years of experience with the following skills current good manufacturing practice cGMP regulations, guidance, and general compliance expectations; technical writing skills; investigational techniques, including but not limited to root cause analysis, risk assessment, impact evaluation, and technical report writing; cGMP data management systems EDMS, Trackwise, andor SAP; and Common Technical Document primarily Chemistry and Manufacturing controls CMC format, content, and filing requirements for U.S. and E.U.br br The alien has a degree in pharmacy which is a degree in the physical or biological sciences, and therefore meets the minimum educational requirement. The experience of quality control andor regulatory experience in a cGMPFDA regulated environment may be gained in any occupational title.
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