无锡招聘

职位描述：
Key accountabilities:
? Act as the project manager and single point of contact for the Pre-Approval Inspection (PAI) preparation initiative, led by QA, for the Wuxi site, as WuXi Bio prepares for its first PAI by the US FDA.
? Track the progress of all projects related to the PAI prep initiative, coordinate with WuXi's staff, and utilize available resources to meet project timelines in a timely and efficient manner.
? Facilitate communication among PAI sub-team project leads, WuXi Bio departments, within QA, and provide updates with the clients.
? Manage and oversee project execution per plan, and manager changes as project scope and/or timeline changes.
? Hold regular internal project meetings to discuss and plan the project within the company.
? Hold regular meetings with clients to update progress via teleconference or site visits as appropriate.
? Maintains records to document all relevant communications related to projects.
? Copies files and mails final reports.
? Assists with training of team members as appropriate.
? Assist with post inspection activities such as CAPAs per audit observations, provide evidence for completion for audit responses, etc, until commencement of PAI certification .


Requirements:
? College degree with major in Science such as Biology, Chemistry, Engineering, Chemical Engineering or equivalent training
? +10 years of pharmaceutical/biotech/biopharmaceutical GMP industry experience is required.
? +5 years of project management experience or equivalent training and/or experience is required. PMP certification is preferred.
? Extensive experiences in Good Manufacturing Practices and/or Good Laboratory Practices for the biopharmaceutical industry is required.
? Strong leadership skills and experiences in leading teams to achieve the project goal.
? Strong communication skills, both verbally and in writing, when leading projects.
? Strong decision-making, conflict resolution, and influencing skills when working in multi-discipline organization with different personalities.
? Ability to work independently with limited supervision
? Ability to work effectively as part of a team and to exhibit effective interpersonal skills.
? Able to multi-tasks and prioritize accordingly while working in a fast-paced work environment.
? Bilingual in both English and Mandarin Chinese, both verbally and in writing.
? Good presentation skills and public speaking. 举报 分享

使命
我们的使命是转变和加快制药发现、开发及在快速成长的生物制剂领域造福全球患者。
公司简介
药明生物技术（药明康德关联公司）提供全面、综合及可高度订制的生物制剂发现，开发及生产服务。我们是世界上唯一的开放式生物制剂技术平台，提供端到端解决方案，让任何人能从概念到商业化生产过程中发现、开发及生产生物制剂。我们提供的单源式服务为客户节省了宝贵的项目时间和费用。我们公司的历史和成就证明了我们为全球客户提供真正的一站式，开放式服务的价值主张和承诺。
更多信息，请登录公司官网：http://www.wuxibiologics.com.cn/