包装Area QA

该职位来源于猎聘 职务描述： Position Brand Description区域 QA负责区域的日常监督，支持，对以下活动提供质量指导：偏差调查，变更控制，流程和主记录的升版，验证，批处理，调试和确认，等。如需要,对其他的区域 QA提供支持。区域 QA的职能在维护 GMP合规和审计的准备过程中意义重大。The area QA provides daily oversight, assistance, and guidance to issues such as non-conformance investigations, change control proposals, procedure / master formula revisions, validations, batch disposition, commissioning, and qualification activities. Advise and provide support to other area QA. The area 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，参与到包装的运营团队中。As QA representative, be active in packaging local process team.有能力评估并区分发生在运营团队中的偏差。Be able to assess and triage 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).参与到六西格玛的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.需要时，支持现场 QA的工作。Be backup of shop floor QA, as necessary.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: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 sciences至少3年的生产或QA经验At least three-year experiences of production or QA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理解生产工艺和质量系统Demonstrate knowledge and understanding of manufacturing process and quality systems较强的技术写作和沟通技巧Demonstrate technical writing and communication skills能用英语听、说、读，写Capable of listening, speaking, reading and writing in English 其他要求：Additional Preferences关注细节Strong attention to detail.有SAP, PMX, TrackWise偏差和变更的使用经验Experience with SAP, PMX and Track Wise Deviation and Change Management processes有可能加班Overtime may be required能接受24小时on call