Jonas Xiao

Experience

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  Zhejiang Jiuzhou Pharmaceutical Co., Ltd.

  Jun 2015 - Mar 2020

  Quality Assurance Group Leader

  1 At a QA team, I’m fully responsible for the daily work of the API line.Including：ü Sample for different materials, ü Production line monitoring,ü Deviation management,ü Change control,ü CAPA managementü OOS management,ü Recyclingü Reprocessingü Complaint,ü Return,ü Recall, ü Validationü Auditü Supplier managementü Product quality review2、 Lead the team through official and customer GMP compliance audits 3、Support the audit management activities (audit planing,audit report,audit response management, and audit follow up)of all audits conducted in supplier audit and internal audit4、Participate in multiple plant renovation projects, DCS control system project, EQMS control system project 5、Write validation master plan ,write process validation protocol /report, write clean validation protocol/report,review equipment qualification protocol/report 6、Batch records review, Product release,7、Quality system implementation and improvemen Show less

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  Shanghai Jingfeng Pharmaceutical Co., Ltd.

  Mar 2020 - now

  Quality Assurance Supervisor

  1、 Establishing quality system for bio-pharmaceutical production line 2、 As a project technical assistant to the general manager，I do my best to push the CMO project from start negotiation to final product delivery. 3、 At a QA team, I’m fully responsible for the daily work of the DS&DP line.Including：ü Sample for different materials, ü Production line monitoring,ü Deviation management,ü Change control,ü CAPA managementü OOS management,ü Complaint,ü Return,ü Recall, ü Validation. 4、Review validation master plan ,review process validation protocol /report, review clean validation protocol/report,review equipment qualification protocol/report5、Lead the team through official and customer GMP compliance audits 6、Organize different kinds of training regularly, the comprehensive abilityOf QA team members has been greatly improved.7、Solid knowledge of GMPs (EU,ICH Q1-13,CN,21CFR),expert in quality system Show less

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  Shanghai BiBo Biopharma Pharmaceutical

  Oct 2021 - now

  QA Supervisor

  It's a new experience