GE HealthCare Production Quality Specialist 

China, Shanghai 

535245441

The main purpose of this position is to assist Production Manager ensure that all operations in the Operation Department are in compliance with cGMP. Coordinating the deviation/change control/complain initiation/investigation/effectiveness check, critical deviation / change control following up, etc.
Job Description

• Assist ProductionDepartment Manager to prepare a yearly quality assurance plan to all employees and ensure its execution.
  协助生产部门经理准备质量保证计划并确保其执行。
• Supervise that the responsible function is in compliance with all relevant guidelines, cGMP and regulations through self-inspection/spot check and document reviewing.
  通过内部的自检和文档的审核，监督指导负责的区域均符合所有相应的法规，GMP和规则。
• Coordinating the deviation/change control/complaininitiation/investigation/effectivenesscheck, critical deviation / change control following up, etc.

• 协调内部门和外部门相关偏差、更改控制及客户投诉的发起，调查，有效性检查，以及追踪关键偏差/更改控制等等。

• Ensure that all operations in the Operation Department are following cGMP. Coordinating compliance team to investigate complaint. Involve compliance team in GMP/productivity project. Be able to analyse operations related data and use risk assessment tools

• 确保生产现场所有生产操作均符合cGMP、协调投诉调查、参与其他与GMP/生产效率相关的改进项目。能分析生产相关的数据和风险分析

• Enrol in internal quality system audit and take the responsibility of follow up actions. Initial deviation/change control/complain investigation and follow up all the Operation Department observations from internal/external, deviations and change controls close out.
  参与内部质量系统审计并负责追踪整改措施的完成。追踪生产部在内部/外部审计中发现的缺陷/偏差/更改控制确保其及时完成。
• Responsible for the introduction of relevant instruments in the production department, data review, and data integrity etc.

• 负责生产部门相关仪器的引入，数据审阅和完整性相关内容。

• Participate in global procedures and external regulatory gap analysis and production related risk assessment

基本资格

• A bachelor's degree or above in a major related to pharmaceutical, food science, or chemistry.

• 药学、食品或化学相关专业大学本科或以上学历

• At least 3 years of working experience in the pharmaceutical or related industry with minimum 2 years of quality/operation management experience.

• 至少3年药厂或相关行业3年工作经验或质量、运营管理2年工作经验

• Good communication skill and presentation skills

• 良好的沟通和陈述能力

• Good English and computer office software skills.

所需特性

Inclusion and Diversity

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.