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Miao Zhang
Associate Partner, China

Miao Zhang.png

  • 4 years of 3rd Party Auditor

  • 2 years of QA China Head in Astellas

  • 3 years of Training/SOP Management/Quality Control in KUNTUO (A Quintiles Company)

  • 3 years of SCRA/PM in L-Wyeth/Pfizer

  • ·3 years of Monitoring in CRO

Specialties

  • GCP Audit & Issue Management

  • Inspection Readiness & Self-inspection

  • GCP training: GCP/ICH-GCP, QA/QC, Inspection/Audit Readiness, Project Management, Site Monitoring, Site Management

  • SOP Development & Management

Experience

  • Performed GCP audits related global & local, Phase I-IV, Oncology & Non-Oncology studies

  • Be inspected by PMDA and CFDI

  • 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

  • Provided the On-job training for the GCP Auditors

  • Provided the GCP training related to monitoring skill (21-days), site management (CRC), inspection readiness, audit readiness, project management

  • Created and managed the training system in KUNTUO (A Quintiles Company)

  • Developed, reviewed and managed the clinical quality system

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