Regulatory Affairs/QA SpecialistGranulation Technology Inc.
Regulatory Affairs/QA Specialist Fairfield, NJ - Ensure organization meets all applicable FDA, cGMP & ICH guidelines/regulations. Prep, complete & authenticate documents with FDA for ANDA. Perform quality management practices including TQM; continuous quality management to monitor pharmacy Process; investigation of quality related product complaints; validation protocols for products, process & facilities to assure quality attributes for company.
Require: Master's in Pharmacy or related.