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制药工程领域专家 徐文勤

作者: 文章来源:弗戈工业在线  点击数:1005  发布时间:2015-05-29

徐文勤 制药工程领域专家

拥有20余年化工、营养品、制药、工程领域专业工作经验。曾指导多家制药企业完善质量管理体系,组织全员培训,并协助其通过法规审核及第二方审核。近7年致力于医药类项目工程设计、项目管理及验证管理。领导团队多次成功完成项目竣工验收及验证活动。

曾先后供职于上海化学试剂总厂质量监督科、罗氏泰山(上海)维生素制品有限公司、上海先灵葆雅制药有限公司、上海药明康德金山厂区(上海合全药业),美施威尔上海有限公司验证经理。

科研成果:

上海罗氏制药有限公司高致敏项目EPCM 2005-2006 验证主管工程师,负责罗氏高致敏项目的工程竣工验收,并按SFDA、EU GMP 要求和罗氏要求对系统进行验证。

南昌梅里亚新建动物疫苗项目(一,二期)EPCMv 2009.5-2012.6验证总监。领导验证团队按照中国兽药GMP 和梅里亚总部要求开展验证管理活动。

深圳迈瑞医疗咨询项目 2011.10-2011.10 项目总监,主审员。

Xu Wenqin, expert in pharmaceutical engineering

 

More than 20 years of professional work experience in chemical, nutrition, pharmaceutical and engineering fields. Guided many pharmaceutical enterprises to improve quality management system, organize all-employee training, and assisted them to pass legal and regulatory audit and second party audit. Near seven years of dedication to pharmaceutical project engineering design, project management and validation management. Led team to successfully complete project completion acceptance and validation activities for many times.

Successively served as Validation Manager in Quality Supervision Department of Shanghai Chemical Reagent General Factory, Roche Taishan (Shanghai) Vitamin Products Co., Ltd., Shanghai Schering-Plough Pharmaceutical Co., Ltd., Shanghai WuXi AppTec Jinshan Factory (Shanghai Syn-The-All Pharmaceutical Co. Ltd.) and M+W Shanghai Co., Ltd.

Scientific research achievements:

Engineer in charge of validation in high sensitization project of Shanghai Roche Pharmaceuticals Ltd. (EPCM 2005-2006), responsible for completion acceptance of Roche high sensitization project, and validation of system in compliance with SFDA, EU GMP and Roche’s requirements.

Validation director of Nanchang Merial’s new animal vaccine project (Phase I, Phase II, EPCMv 2009.5-2012.6); led validation team to carry out validation management activity according to Chinese veterinary drug GMP and Merial Headquarters’ requirements.

Director and chief auditor of Shenzhen Mindray medical treatment consulting project (October, 2011-October, 2011)

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