An experienced, progressive thinking quality professional with experience in Pharmaceutical/Biotechnology/Medical Device industries. A certified Quality Assurance, Quality Control and Regulatory professional with broad range experience in Quality Assurance (Quality System), Quality Control, project management, analytical method development, CMC and regulatory compliances in cGMP/GLP/GCP research and manufacture environment. Knowledgeable of CDER, CBER, ISO, JP and EU requirements. Experienced in FDA/ISO/EU audits, A dynamic result driven leader with exceptional leadership skills in planning, recruiting, coaching, developing, and motivating staffs. Familiar with analytical and microbiolo...
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