Job Description Summary

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 youd expect from an organization with global strength and scale and youll be surrounded by career opportunities in a culture that fosters care collaboration and support.

Additional Information