Tracy Feng

Experience

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  Livzon

  Mar 2009 - May 2013

  Technician / Registration Affairs Supervisor

  Microorganism technician for improving the strains’ production capacity. Fermentation department for process control QC lab for routine product analysisReg. Affairs specialist for domestic human and veterinary registration.Reg. Affairs supervisor and registered registration specialist in Guangdong FDA.Responsible for the all registration affairs, including oversea registration (e.g. US-FDA, Health Canada, EDQM) and domestic registrations.Participated in all affairs related English including paper and oral translation, participate in on-site Inspections from authorities (US-FDA, CFDA) and audits from customers, reply on oversea customer’s questions, etc. Show less

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  德恩GMP咨询 | gempex China

  May 2013 - now

  Responsible for business and company developmentGMP consultant, focus on strategy compliance planGuiding GMP projects assuring the quality, including international audits, inspection readiness projectsExperience: with more than fifty audits and inspection projects executed, and guide more than hundreds compliance projects GMP expert and Management assistance; Business development & financial affairsAudit organization /Audit executionCEP/ ASMF/ DMF projects responsibility.Technical support for all kind of GMP projectsGMP TrainingsOn-site translation for all kinds of seminars and workshop

  • Vice General Manager

    Sept 2017 - now

  • GMP Expert I Management Assistance

    May 2013 - Sept 2017