产品质量保证专员

该职位来源于猎聘 The QA provides daily oversight, assistance, and guidance to issues such as non-conformance investigations, change control proposals, procedure, validations, batch disposition, and qualification activities. Advise and provide support to other area QA. The QA position is essential for maintaining GMP compliance and providing support during preparation for inspections.

主要职能： Key Objectives/Deliverables: 在质量问题上，领导，指导并辅导运营和支持部门的人员。 Lead, mentor, and coach operations and support personnel on quality matters. 保证经常在现场监督 GMP行为和质量系统的运作。 Ensure regular presence in operational areas to monitor GMP programs and quality systems. 作为 QA代表，参与到临床包装的运营团队活动中。 As QA representative, be active in clinical packing operation. 有能力评估并调查发生在运营团队中的偏差。 Be able to assess and investigate deviations that occur within the local process team. 当发生产品相关的问题时（如：内部投诉，外部投诉调查，等），能够和支持部门或者外部合作伙伴一起解决问题，或者为解决问题提供意见。 Work with support teams and external partners to resolve or provide advice on product related issues (e.g., intro company issues, complaints investigation, etc.) . 参与到工厂自检中，对内部或者外部的审计提供支持。 Participate in self-led inspections and provide support during internal /external regulatory inspections

能够有效的审核或批准文件，保证满足产品质量的要求（如：偏差，规程，技术研究，验证方案，变更和工程文件）。 Be able to effectively review or approve documents to ensure quality attributes are met (e.g., deviations, procedures, technical studies, validation protocols, change controls and engineering documents).

参与到精益项目或者工艺流程改进中，支持质量部门和生产区域的效能提升。 Participate in Six Sigma Projects to help improve productivity within the local process team or quality organization. 作为 QA代表，支持运营团队的项目和工艺改进。 Support project and process improvement initiatives in the local process team as the QA function. 遵守HSE各项管理流程，履行安全生产职责要求 Follow various HSE management procedures and fulfill the work safety responsibilities

基本要求： Basic Requirements: 61 本科及以上学历，药学化学或相关学科 Bachelor degree or above, major in pharmaceuticals, chemistry or related science 61 至少3年的生产或QA经验 At least three-year experiences of production or QA 61 展现出较强的口头和书面沟通和人际交际技巧 Demonstrate strong oral and written communication and interpersonal skills 61 展现出较强的做决定和解决问题的技能 Demonstrate strong decision making and problem solving skills 61 理解生产工艺和质量系统 Demonstrate knowledge and understanding of manufacturing process and quality systems 61 较强的技术写作和沟通技巧 Demonstrate technical writing and communication skills 61 能用英语听、说、读，写 Capable of listening, speaking, reading and writing in English

61 关注细节Strong attention to detail. Additional Preferences 61 有JDE, TrackWise

有JDE 和trackwise 系统的使用用经验 Experience with JDE and Track Wise Deviation and Change Management processes 61 无菌产品和生物原液审计经验是加分项Experience of GMP auditor on drug substance and sterile product manufacture is a plus