Requires Bachelors degree in Information Technology, Engineering, Science or related field. Also requires 5 years of experience in an FDA regulated industry working on Computerized System Validation CSV activities; 5 years of experience in the following applying FDA regulations, including CFR 21 Part 820, Part 11; working within published FDA device regulatory guidelines and using internal standard operating procedures; and implementing the VModel GAMP.br Domestic travel up to 15 of the time.
Categorias: eb3
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