奥星集团验证咨询服务部经理马义岭

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马义岭(Peter Ma)，从事制药行业工作16年，验证工作10年以上。现任奥星集团验证咨询服务部经理，负责管理100多人的验证团队。曾承担并完成多个大型制药企业和合资药厂的国际认证验证项目，涉及疫苗、生物制剂、无菌制剂、固体制剂和原料药等产品的验证及GMP合规性咨询服务。具有丰富的项目管理经验和验证经验，熟悉制药企业各类验证工作、相关法规和指南及各种验证仪器的操作。具有组织团队进行风险分析，验证主计划编制及验证管理，洁净空调系统验证，水系统验证，工艺设备验证和自控系统验证的能力与知识。现为国际制药工程协会(ISPE)中国分会会员发展委员会委员，同时为ISPE调试与确认课程的讲师。

Mr. Ma Yiling (Peter Ma) has been engaged in the pharmaceutical industry for 16 years with an experience in validation activities for more than 10 years. He is the manager of the Validation Consultancy Service Department of Austar Group and is responsible for the management of the validation team with more than 100 engineers in Austar. He has ever undertaken and accomplished a number of international certification and validation projects for numerous large domestic pharmaceutical enterprises and joint ventures and such validation projects involve validation services for all such products as vaccines, biological products, sterile products, solid dosage forms and APIs, and GMP conformance service. He has rich experience in project management and validation and is familiar with the various kinds of validation activities in pharmaceutical enterprises, relevant regulations and guidance, and operation of various kinds of validation instruments. He has the capability and knowledge in organizing his team in performing such validation activities as risk analysis, Validation Master Plan preparation, validation management, clean HVAC system validation, water system validation, process equipment validation and automation system validation. He is a member of the Promotion Sub-committee of International Society for Pharmaceutical Engineering (ISPE), meantime, he is also a qualified instructor for C&Q course.