徐文勤:智能制造在制药业的应用研究

作者:本网编辑 文章来源:PHT《制药业》 点击数:99 发布时间:2017-08-29
徐文勤制药&制药工程领域专家...
徐文勤:智能制造在制药业的应用研究

徐文勤制药&制药工程领域专家...

拥有24年化工、营养品、制药、工程项目管理及药事合规化咨询领域专业工作经验。曾指导多家制药企业完善质量管理体系、应对国内外法规审核。近十余年致力于生命科学类项目工程设计、项目管理及验证管理,数十个外资大型生命科学类项目质量及合规化规则制定人。领导团队多次成功完成项目设计审核、竣工验收及验证活动。

曾先后供职于上海化学试剂总厂、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(合全药业)、美施威尔(上海)有限公司和美国Pharmatech Associates Inc.中国分公司。

主要工作成果:

苏州惠氏营养品项目2007-2010,质量及合规化规则制定人。

上海诺华研发中心项目2009-2014,质量及合规化规则制定人。

苏州信达制药单抗验证管理项目2013-2014,项目拥有人及总顾问。

南昌梅里亚新建动物疫苗项目2009-2012公司层面验证团队总负责人。

湖南南岳生物新建血液制品验证管理及质量合规化咨询项目2014-2015,项目拥有人及总顾问。

Xu Wenqin,Tom, expert in pharmaceutical &pharmaceutical engineering

24+ years professional work experience in chemical, nutritional, pharmaceutical, project management and pharmaceutical regulatory affair fields. Lead quality management system development progress for many pharmaceutical enterprises which aim to international regulatory audit.Focus on design, project management and validation management for life science projects over the past decade. Principal in quality and regulatory compliance principles for dozens of large-scale foreign owned LS projects. Lead team to successfully complete design review,as-built acceptance and validation activities for many times.

Previously worked for Shanghai No. 1 Chemical Reagent Factory, Roche Taishan (Shanghai) VitaminsProduct Co., Ltd., Shanghai Schering-Plough Pharmaceutical Co., Ltd., WuXiAppTecJinshan Factory ( ShanghaiSyn-The-All),M+W Shanghai Co.,Ltd. And Pharmatech Associates Inc.(US)-a partner company in China.

Major workachievements:

Wyeth Nutritional greenfield project, Suzhou,2007-2010, Principal in quality and regulatory compliance principles.

Novatis R&D Campus project,Shanghai, 2009-2014, Principal in quality and regulatory compliance principles.

InnoventMab greenfield project, Suzhou, 2013-2014, Validation management project shakeholder and chief consultant.

Merial Animal Vaccine project, Nanchang, 2009-2012, Principal in joint validation team, company level.

Nanyue bio-pharma new blood product plant, Hunan,2014-2015, Validation & GMP consulting service, project shakeholder and chief consultant.