Chi Huynh

Experience

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  United Pharma Vietnam

  Oct 2000 - May 2011

  • Regulatory Affairs Specialist

    Jun 2009 - May 2011

  • Qc Supervisor

    Jan 2007 - May 2009

  • Qc Analyst

    Oct 2000 - Dec 2006
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  Pharmamate Representative Office

  May 2011 - Nov 2011

  Regulatory Affairs Manager
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  Janssen, Pharmaceutical Companies of Johnson and Johnson

  Dec 2011 - May 2023

  Commercial Quality Associate Manager

  - Manage and implement the quality processes of Janssen Vietnam including Escalation, Field Action, Management Review, CAPA, Non-conformance, Change Control, Product Quality Complaint, Internal audit…. Prepare, update local procedures in accordance with local regulation, applicable cGxP and corporate requirements.- Handle the temperature excursion of cold chain products during shipment, storage and distribution.- Deploy electronic systems for Quality Issue, CAPA, Change Control, Complaint handling, Audit management at J&J Vietnam. - Deliver training in quality process to local team.- Manage the implementation of new product labels as per local regulation and company requirement.- Manage local suppliers and distributors through the process of selection, qualification, assessment, audit, monitoring of suppliers and distributors- Co-ordinate with regional team in local manufacturing project- Co-operate with technical global team to execute the technical transfer to local manufacturer.- Responsible for ensuring quality standards are achieved and maintained at new under qualification local third-party manufacturer, through on-site management and oversight of Quality Operations functions. This oversight includes ensuring continuous compliance to relevant regulatory health authority requirements.- Functions and activities include Quality assurance review and/or approval functions (such as Non-conformance, CAPA, Change Control, Validation report, stability report…), Compliance audit activities. - Ensure business, quality and compliance goals are met in full compliance with all company Supply Chain and government-issued environmental, health, safety, quality and regulatory policies and guidelines Show less

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  Kenvue

  May 2023 - now

  Commercial Quality Manager