Seeking an individual with extensive experience with GMP’s and the Q7 guideline. A small German firm located close to Munich is seeking an individual to advise the firm on GMP matters and API manufacturing as well as to assume the role of U.S. Regulatory Agent. The current part-time Regulatory Agent is retiring after 25 years. After an initial interview with the current Regulatory Agent in the US, a potential candidate will visit the site to meet with the firm’s management, discuss relevant issues and take a tour of the laboratories and the production facility. This site has already undergone four successful FDA inspections.
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