Miao Zhang
Associate Partner, China
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4 years of 3rd Party Auditor
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2 years of QA China Head in Astellas
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3 years of Training/SOP Management/Quality Control in KUNTUO (A Quintiles Company)
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3 years of SCRA/PM in L-Wyeth/Pfizer
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·3 years of Monitoring in CRO
Specialties
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GCP Audit & Issue Management
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Inspection Readiness & Self-inspection
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GCP training: GCP/ICH-GCP, QA/QC, Inspection/Audit Readiness, Project Management, Site Monitoring, Site Management
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SOP Development & Management
Experience
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Performed GCP audits related global & local, Phase I-IV, Oncology & Non-Oncology studies
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Be inspected by PMDA and CFDI
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By the end of 2020, participated in the preparation for on-site inspection of 17 pharmaceutical companies, and 6 of their products (Merck, Astellas, Innovent, Junshi, Cstone, ZaiLab) have been launched/passed the on-site inspection successfully
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Provided the On-job training for the GCP Auditors
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Provided the GCP training related to monitoring skill (21-days), site management (CRC), inspection readiness, audit readiness, project management
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Created and managed the training system in KUNTUO (A Quintiles Company)
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Developed, reviewed and managed the clinical quality system