B****4
发帖数: 24 | 1 本人背景：
5年制药行业供应商质量工作及API 采购经验 （2年在外资）
1.供应商GMP审计
2.QA/QC Compliance经验
3.Regulatory lifecycle management
4.DMF review经验
本科：生物工程
目前： 在MCPHS University 主修：drug regulatory & QA, minor on
pharmaceutical science
课程内容主要涉及：
Regulatory: pre-IND, IND application, clinical trial operation, BLA/NDA, CMC
regulatory management, IND dossier preparation, GXP
QA: GMP audit, CAPA, ICH Q7,8,9,10, Change control, OOS/SST, Documentation
system
Pharmaceutical science: industrial pharmacy (Advance pahysical pharmacy,
chromatography nalytical methods development & validation, formulation:
granulation)
Biostatistic: SAS software, epidemiology.
课外活动：
1. Initiated ISPE MCPHS University Students Chapter (President of chapter)
2. Biogen Idec manufacturer plant tour (ISPE young professional educational
program)
3. AAPS Poster session.
兴趣方向：
1. CMC management
2. QA Compliance
3. GMP
4. Technical outsourcing supporting (CMO, raw material)
希望前辈指教如何在找INTERN 和工作。 |
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