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... processes to determine compliance with regulatory requirements, guidelines and established standard ... an emphasis on technical expertise, regulatory risk, and quality advice. GQ-QLP ... also responsible or coordination/management of..
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... activities to ensure patient safety, regulatory requirements and improve its effectiveness ... Product Deviation Reports for the FDA or the equivalent notifications to ... Thorough understanding of cGMPs and..
... (cGMPs), Food and Drug Administration (FDA) standards, relevant foreign drug regulatory standards, established specifications, and drug ... purview. She/he is recognized as subject matter expert in the principles and..