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。
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。
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。
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
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。
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。
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
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。
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.
Relocation Assistance Provided: No
