加入会员日期: Mar '12

工作语言:
English英语译成Chinese汉语
Chinese汉语译成English英语

Igor Lee
Senior GMP Translator & GMP Interpreter

Shanghai, Shanghai, 中国大陆
当地时间23:05 CST (GMT+8)

母语为:Chinese汉语 Native in Chinese汉语, English英语 Native in English英语
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What Igor Lee is working on
info
Oct 10, 2025 (posted via ProZ.com):  Supported a lab in Hangzhou to accept FDA audit (interpreting), with successufl results, i.e. zero-observation, without 483 ...more, + 14 other entries »
Total word count: 9632

账户类型 自由笔译员和/或口译员, Identity Verified 已获验证的会员
Data security Created by Evelio Clavel-Rosales This person has a SecurePRO™ card. Because this person is not a ProZ.com Plus subscriber, to view his or her SecurePRO™ card you must be a ProZ.com Business member or Plus subscriber.
附属机构 This person is not affiliated with any business or Blue Board record at ProZ.com.
服务 Editing/proofreading, Translation, Interpreting, Website localization
专长
专业领域:
商务/商业(普通)化学;化学/化工
工程(总称)安全
制造业证书、毕业证、执照、个人简历
核能/核子科学Medical: Oncology

志愿服务/公益服务 会考虑为注册的非盈利机构提供志愿服务。
费率
General rate: 0.06 USD per word / 30 USD per hour

Rates per language pair:
English英语译成Chinese汉语 – 费率:0.06 - 0.08 USD每字 / 30 - 40 USD每小时
Chinese汉语译成English英语 - 费率:0.06 - 0.08 USD 每字 / 30 - 40 USD 每小时
All accepted currencies U. S. dollars (usd)
KudoZ活动 (PRO) 专业级别答题积分 29, 回答的问题: 17
此用户的Blue Board记录  2 评价

翻译样本 已提交的翻译样本: 9
翻译相关教育经历 Master's degree - Yunnan Agricultural University
经验 已有23年翻译资历。 在ProZ.com网站的注册时间:Mar 2012。 成为会员时间:Mar 2012
ProZ.com Certified PRO certificate(s)
证书 English英语译成Chinese汉语 (CATTI(Level 2)-China Accreditation Test for Translators and Interpreters, verified)
Chinese汉语译成English英语 (CATTI Level-2, verified)
Chinese汉语译成English英语 (CATTI (Level 1), verified)
English英语译成Chinese汉语 (CATTI (Level 1), verified)
会籍 N/A
软件 Adobe Acrobat, Adobe Illustrator, Adobe Photoshop, AutoCAD, DejaVu, Dreamweaver, FrameMaker, Frontpage, Indesign, memoQ, Microsoft 365, Microsoft Excel, Microsoft Word, SDL Trados Studio 2019, Powerpoint, SDLX, Trados Studio
网址 http://www.proz.com/profile/1566236
CV/Resume English英语 (PDF)
行业规范 Igor Lee 支持 ProZ.com's 职业操守指引.
Professional objectives
  • Meet new translation company clients
  • Meet new end/direct clients
  • Work for non-profits or pro-bono clients
  • Screen new clients (risk management)
  • Network with other language professionals
  • Help or teach others with what I have learned over the years
  • Improve my productivity
档案

Since 2011, I have been deeply involved in translating & interpreting for GMP audits, FDA audits, and pharmaceutical computerized system validation (CSV)/GAMP5 audits for pharmaceutical companies (covering pharmaceuticals, medical devices, and laboratories) across China on an annual basis. To date, I have accumulated over a hundred instances of GMP audit interpretation experience (fourteen years).

My Online CV: https://www.proz.com/profile/1566236

Since first collaborating with an independent Spanish GMP auditor in 2011 (using English as the audit language), our highly successful initial partnership has evolved into a long-term collaboration (now entering our 14th year). Annually, the Spanish auditor conducts multiple audit tours in China, each covering several pharmaceutical manufacturers. Over the past fourteen years, we have jointly audited over a hundred pharmaceutical plants. Beyond this primary collaboration, I actively participate in GMP audit interpretation projects for other clients. Since 2019, I also supported Chinese domestic pharmaceutical companies to accept various GMP audits by foreign regulatories. Selected GMP audit interpretation projects I have engaged in include:

1. Jul 14-16, 2025  

Supported a lab in Hangzhou to accept FDA audit (interpreting), with successufl results, i.e. zero-observation, without 483.

 

2. Jul 2, 2025  

Supported GMP audit conducted by a Spanish pharmaceutical company (buyer) at a Dalian API manufacturer (supplier), serving as interpreter for the Spanish auditor.  

 

3. Jun 26, 2025  

Supported a CAR-T cell therapy manufacturer (Nanjing) to carry out GMP audit for its contracted USA BSL-3 laboratory.  

 

4. May 26-30, 2025  

Served as lead auditor's interpreter for Egyptian Drug Authority (EDA) official audit at Tianjin vaccine manufacturer.  

 

5. Apr 14-17, 2025  

Interpretating for Indonesian Drug Authority official audit at a sterile injectables plant (Jilin Province), my area focused on on-site verification of registration documents (including quality studies).  

 

6. Feb 22-27, 2025  

Supported QC auditor during Egyptian Drug Authority (EDA) official audit at a sterile injectables plant (Jilin Province).  

 (Note: I was recommended as an interpreter for this project, based on positive client feedback from previous Egyptian Drug Authority audit in Shandong)  

 

7. Jan 10-13, 2025  

Interpreting for QC auditor during Egyptian Drug Authority (EDA) official audit at Shandong sterile injectables facility.  

 

8. Dec 17-18, 2024  

Provided interpretation services for TÜV (Poland) to audit a medical device company (Shandong Province).  

 

9. Dec 9-13, 2024  

Interpreted for UK GMP expert during PIC/S & EU GMP gap analysis audit at Inner Mongolia sterile injectables plant, commissioned by leading Chinese consultancy.  

 

10. Nov 18-23, 2024  

Supported ANVISA pre-approval audit interpretation at Jilin sterile injectables facility.  

 

11. Nov 11-13, 2024  

Served as lead auditor's interpreter for WHO PQ audit (HPV diagnostic kits) at multinational pharma's Shenzhen site, receiving commendation from WHO team (France/Oman).  

 

12. Oct 30, 2024  

Provided GMP interpretation for Brazilian client QA audit at Suzhou biologics plant.  

 

13. Oct 28, 2024  

Facilitated interpretation for Bangladesh's largest pharma (Circle Ltd) during audit at Jilin sterile injectables facility.  

 

14. Sep 19-20, 2024  

Interpreting for a GMP audit (cell banking/facilities) conducted by Polish auditors (client/third-party auditors) at Shanghai cell therapy leader.  

 

15. Aug 16, 2024  

Supported Brazilian client QA audit interpretation at Suzhou biologics plant.  

 

16. Jul 29, 2024  

Provided interpretation for third-party Indian auditor (representing Bangladesh client) at Suzhou biologics facility.  

 

17. Jun 24, 2024  

Interpreted for Ukrainian client QA audit at Suzhou biologics plant.  

 

18. May 16-17, 2024  

Served as lead interpreter during Tanzanian Drug Authority (TMDA) on-site GMP audit at Changzhou sterile injectables facility, resulting in successful certification.  

 

19. May 7-10, 2024  

Supported long-term Spanish auditor during GMP audits at Hangzhou & Taizhou pharmaceutical plants.  

 

20. Mar 19, 2024  

 Facilitated remote GMP audit interpretation for Chinese pharma's evaluation of Indian API supplier.  

 

21. October 25-27, 2023

Interpreting for an FDA audit of a testing laboratory

 

22. June, 2023

GMP audit interpretation for pharmaceutical factories in Changzhou, Emeishan, Nantong Haian, Shanghai and other places, as well as GMP audit interpretation for Pharmaron (Remark: Pharmaron is the TOP 2 leading CDMO corporate in China) Beijing Branch, Ningbo Branch and Tianjin Branch.

 

23. September 2, 2022

Interpreting for a remote GMP audit of a pharmaceutical plant in Shenyang, Liaoning

 

24. December 2, 2021

Interpreting for remote GMP audit of a pharmaceutical plant in Shangyu, Zhejiang

 

25. July 6, 2021

Interpreting for remote GMP audit of a pharmaceutical plant in Yancheng

 

26. April 18, 2021

Interpreting for remote GMP audit of a pharmaceutical plant in Cixi, Ningbo

 

27. April 16, 2021

Interpreting for remote GMP audit of a pharmaceutical plant in Shangyu, Shaoxing

 

28. April 15, 2021

Interpreting for remote GMP audit of a pharmaceutical plant in Tianjin

 

29. March 31, 2021

On-site interpreting for GMP audit of a pharmaceutical plant in Taizhou

 

30. November 2020

On-site interpreting for GMP audit of a pharmaceutical plant in Nantong

 

31. October 2020

Interpreting for a CRO company in conducting a computerized system (CSV) GAMP5 audit of a pharmaceutical software company. The auditor was Indian and the audit was conducted remotely. (covering clinical trials and IT)

 

32. August 2020

On-site interpreting for GMP audit of CSPC Pharmaceutical Group in Shijiazhuang

 

33. October 30 to November 9, 2017

On-site interpreting for GMP audit of four pharmaceutical plants in Taicang, Jiangsu, Shangrao, Jiangxi, Xinxiang, Henan, and Shijiazhuang, Hebei.

 

34. July 11 to 12, 2017

On-site interpreting for GMP audit of a pharmaceutical plant in Shenyang

 

35. March 23rd to 28th, 2017

On-site interpreting for GMP audit of two pharmaceutical plants of Sinopharm Holdings in Nantong and Shanghai.

 

36. August 6 to 25, 2016

On-site interpreting for GMP audit of 12 pharmaceutical plants in China.

 

37. June 2014

On-site interpreting for GMP audit of pharmaceutical plants in Taicang, Jiangsu, Chizhou, Anhui, Tiantai County, Zhejiang, and Shijiazhuang.

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总积分: 29
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语言 (专业)
English英语译成Chinese汉语29
主要普通领域 (专业)
技术/工程设计9
其它8
法律/专利4
商务/金融4
社会科学4
主要专业领域 (专业)
IT(信息技术)8
保险8
化学;化学/化工4
教育/教育学4
法律:税与海关4
电信1

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This user has reported completing projects in the following job categories, language pairs, and fields.

Project History Summary
Total projects4
With client feedback0
Corroborated0
0 positive (0 entries)
positive0
neutral0
negative0

Job type
Interpreting3
Translation1
Language pairs
English英语译成Chinese汉语4
Specialty fields
Other fields
关键词: CAT ( Trados) User -Senior English-Chinese Nuclear Translator (TTechnical Translator, Engineering Translator, Nuclear Translator, Chemical Translator, Shipbuilding Translator, and Pharmaceutical GMP/FDA Translator) -Shanghai (China) Chinese Interpreter-Technical Translator-Technical Interpreter


简介页面最后更新时间
Oct 10, 2025