Sr QA Specialist job opportunity at GE HealthCare.

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DatePosted 27 Days Ago bot
GE HealthCare Sr QA Specialist
Experience: General
Pattern: full-time
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loacation Shanghai, China
loacation Shanghai....China

Job Description Summary This position is primarily responsible for quality oversight and compliance management at the GE Healthcare (Shanghai) Co., Ltd. The core responsibilities include real-time monitoring of production processes, life-cycle management of Deviations and Corrective and Preventive Actions (CAPA), batch record collection, and retention sample inspection. Ensure that all manufacturing activities strictly adhere to national and international GMP regulations while actively upholding the plant’s EHS (Environment, Health, and Safety) standards. 本岗位主要负责通用电气药业（上海）有限公司生产现场的质量监督与合规性管理。核心任务包括生产过程的实时监控、偏差（Deviation）与纠正预防措施（CAPA）的全生命周期管理、批记录收集以及留样检查。确保生产活动严格符合国家及国际 GMP 法规要求，并积极维护工厂的 EHS（环境、健康、安全）标准。 GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world. Job Description Roles and Responsibilities角色职责 Batch Record 批文件 Support product release group to collect batch record from manufacturing department. 支持放行组从生产部门接收批文件。 On site inspect 在线检查 Monitor the production. By inspection randomly and control, make sure the environment, equipment, person, material, procedure and record in manufacturing spot meet with specification. Ensure the manufacturing spot, process meet with compliance and record is complete, timely, meet with fact. Record the abnormal situation in spot and give out the response timely. 进行在线监控，从环境、设备、人员、物料、程序、记录角度对生产现场进行抽查和控制，保证生产过程中生产环境、生产操作的合规，生产记录的完整、及时、真实可靠。对生产现场发生的异常进行记录并及时给与反馈。 Record the non-conformance as deviation in TWD system, and follow-up the implementation of corrective actions during on line inspection. 在TWD报告不符合项，并在现场检查中跟踪纠正预防措施的实施。 Inspection of retention sample 留样检查 Perform the Retention/Reference sample check in accordance with the sample checklist. 根据留样检查表检查留样/参比样。 Maintain deviation system and deviation handling 维护偏差系统和对其的处理 Handle deviations in TWD system to ensure that the proper investigations were performed and the enclosed documentations are compliant with the current procedures and standards. It is important to work together with other departments to allow following of corrective and preventive actions and ensuring the overall smooth running of the deviation system. 对TWD中的偏差及时进行处理，以确保对偏差已进行了合适的调查，附上的文件符合当前的规程与标准。跟踪纠正预防措施与确保整个偏差系统的顺利运行需要与其他部门紧密合作。 Support Product Complaint Handling 支持产品投诉的处理 Support the investigation of product complaint if necessary, such as monitoring of manufacturing process as part of root cause analysis. 必要时支持产品投诉的调查，如作为根本原因分析的一部分，对制造过程进行监控。 Associated CAPA Control System 相关的 纠正和预防措施控制系统 Track the status of all the CAPAs from deviation etc. via TWD system. To ensure that corrective and preventive actions taken were appropriate and completed within timeline. 跟踪在TWD系统里的从偏差等情况下产生的纠正预防措施的状态。确保纠正预防措施在规定时间内完成以及它们的合理性。 Approve CAPA PRs after training and qualification. 培训获得资质后批准纠正和预防措施。 Project participation 项目的参与 Participate in plant projects and provide QA support. 参与工厂项目，提供QA支持。 General responsibilities 一般职责 Assist QA Supervisor and Manager with routine departmental activities such as compilation of monthly reports. 协助质量保证主管和经理进行日常部门工作如写月度报告等。 Generally provide support in QA activities. Work together with other Departments and responding to routine quality related queries 对质量保证活动提供支持。与其他部门一起处理日常质量问题。 Write or revise relevant SOP related to his/her responsible area. 起草或修改与工作范围内相关的SOP。 Take part in audits when that is required. 根据需要参加审计。 To assure that any information regarding non-compliance according to new or already active guidelines and regulations are acted upon. 确保对所有与已存在的或新的规范不符的情况采取措施。 Basic Eligibility基本资格 Relevant College/University degrees (Engineer etc.) is essential. 具备相关大专或本科学历（工程师） Thorough knowledge of national and international GMP requirements. 熟悉国内和国际GMP法规 QA, QC or production experience is preferred. QA, QC或生产工作经验优先 Required Character所需特性 Excellent verbal and written communication skills. Excellent interpersonal skills. Ability to influence others and coordinate multiple projects simultaneously. Effective problem identification and resolution skills. 优秀的口头和书面沟通能力。优秀的人际关系能力。能够影响他人能够同时协调多个项目。有效的问题识别和解决技能。 Inclusion and Diversity GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity. Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support. Additional Information Relocation Assistance Provided: No

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