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QA 总监/高级总监

面议

苏州市硕士及以上

刷新时间:2天前

职位描述

QA 总监/高级总监 Job Responsibilities:
工作职责:
 The QA lead for the company, plays an essential role in maintaining and continuously enhancing the quality service brand of A Bio in the industry, both domestic in China and abroad, as well as among relevant government agencies.
  担任公司 QA 负责人,在维护和不断提A生物在国内外行业和相关政府机构内的优 质服务品牌方面有着至关重要的作用。
   As the senior QA leader of the company, work closely with the company CEO to complete all aspects of QA strategic deployment and daily operations, which includes providing quality system framework and documents that meet customers’ needs, participating in system implementation and training, customer and CDMO on-site auditing, GMP document review and approval, leading company internal and customer deviation, change, product release, quality risk assessment, supplier qualification and other specific QA management processes, participating in manufacturing and lab facility build and qualification as well as client and regulatory agency compliance audit preparation and submissions.
  作为公司高级 QA 领导,与公司首席执行官密切合作,完成 QA 战略部署和日常运营的各个方面,包括提供满足客户需求的质量体系框架和文档、参与系统实施和培训、客户 与 CDMO 现场审核、GMP 文件审核和批准、领导公司内部和客户偏差、变更、产品发 布、质量风险评估、供应商资格认证以及其他具体的 QA 管理流程、参与制造和实验室 设施建设和资格认证,以及客户和管制机构合规审计的准备和提交。
   Lead QA team building, personnel development and performance evaluations.
  领导 QA 团队建设、人员发展和绩效评估。
   As a senior manager of the company, make a key contribution to the company's medium and long-term planning and strategic goal setting, including market development and new business development.
  作为公司的高级经理,为公司的中长期规划和战略目标设定做出重要贡献,包括市场开 发和新业务发展。
   Required to work closely with the relevant department leaders of the company and customers in order to achieve the overall goal of the company.
  需要与公司相关部门领导和客户密切合作,以实现公司的总体目标。
  Job Requirement 岗位要求
   Master /Doctorate degree in Molecular Biology, Biological Engineering, Pharmacy, Chemistry or equivalent, Ph.D highly desirable.
  分子生物学、生物工程、药学、化学等相关专业的硕士/博士学历,博士优先。
   More than 12 years’ experience in pharmaceutical industry, including not less than 8 years of QA or GMP quality leadership experience in multinational US or European countries. Must have at least 5 years of relevant biopharmaceutical experience, including product development.
  在制药行业有 12 年以上的工作经验,包括在欧美国家不少于 8 年的 QA 或 GMP 质量领 导经验。必须有至少 5 年的相关生物制药经验,包括产品开发。
   Familiar with relevant regulations of cGMP and ICH in US and Europe, and have experience in IND-BLA registrations. 熟悉欧美 cGMP 和 ICH 的相关法规,具有 IND-BLA 注册经验。
   Strong sense of responsibility, integrity, high precision work style.
   责任心强,诚信,高精度的工作风格
   Strong ability of team/organizational management and rich experience in third-party cooperation.
  较强的团队/组织管理能力,具有丰富的第三方合作经验。
   Fluent in oral and written English skills, including technical writing.
  精通口语和书面英语技能,包括技术写作。  

其他要求

  • 1人
  • QA总监/QA经理/QA主管

公司介绍

诗迈医药猎头是一家专业从事医药行业猎头服务的科技型企业,总部位于杭州,下属有上海、南京、广州、武汉等多家分公司,同时自主开发国内领先的猎头办公系统及医药人才网站,全面致力于海内外制药、生物、医疗、器械等行业线上线下人力资源整合。
公司与全国各地研发企业、生产企业及销售经营等企业及业内同行建立了良好互动平台,在欧、美、日等国家建立了海归引进平台,同时积极开展医药高等院校公益系列讲座,搭建了以人力、企业为主体的立体化咨询服务网,为医药企业人才队伍建设发挥了积极重要作用,为很多医药企业解决了高端人力之困。

所在城市:
所任职位:
BP

企业信息

名称:
诗迈医药猎头
行业:
制药.生物
性质:
私营/民营企业
规模:
1-49人

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