With extensive experience in the pharmaceutical and medical device industry, I specialize in regulatory compliance, quality assurance, and risk assessment. My skill set includes comprehensive knowledge of USFDA, CFDA, PIC/s, EU GMP, GxP, and ISO standards. I excel in conducting compliance audits, providing GxP training, and managing supply chains while emphasizing GMP, quality, and manufacturing standards. My background also encompasses validation processes. Overall, I am a seasoned professional committed to ensuring pharmaceutical and medical device companies meet rigorous industry standards while optimizing their operations.
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