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Job Function:

Quality

Job Sub Function:

Quality Control

Job Category:

Professional

All Job Posting Locations:

Xian, Shaanxi, China

Job Description:

• 负责实验室相关项目的管理。

Responsible for the laboratory projects management

• 确保数据完整性。

Ensure data integrity of laboratory.

• 正确操作及维护实验室日常设备。

The correct operation and maintenance of laboratory equipment.

• 正确操作实验室相关软件：如eLIMS, SQC等。

The correct operation of laboratory software, e.g. eLIMS, SQC, etc.

• 实验室其他相关工作：如卫生区域维护，台账管理等。

The other laboratory works: e.g. housekeeping, logbook management, etc.

• 了解所有与职位相关的J&J的安全、环境、工业卫生规范，在工作过程中严格执行并遵守。Comply with environmental, safety and industry hygiene regulations and J&J requirements.
• 人员培训工作。

Training the analysts.

• 负责实验室NC, OOT/OOS等事件的调查。

Responsible for lab investigation of NC/OOT/OOS and other laboratory issues.

• 负责实验室相关变更，纠正预防措施等。

Responsible for laboratory COC, CAPA, etc

• 负责实验室相关文件的起草，升版，复核及相关系统更新维护申请。Responsible for laboratory documents’ drafting/updating/ reviewing and maintenance application of related system.
• 稳定性管理。

Stability management.

• 及时发现并解决实验室相关问题。

Find and solve the laboratory problems timely.

• 负责实验室相关项目的管理。

Responsible for the laboratory projects management

• 熟悉并优化实验室流程。

Improve laboratory process

• 严格依据质量标准/检验方法及实验室的各项管理规范及时准确地完成对原料、辅料、包材、产品、稳定性样品及其他化学检验产品样品等的检验工作。Execution of chemical tests and quality control for material/excipients/packing materials /products/stability samples and other samples according to the specification/test method and the laboratory’s management practices.

 

 

Required Skills:

 

 

Preferred Skills:

Analytical Reasoning, Business Behavior, Compliance Management, Controls Compliance, Cross-Functional Collaboration, Innovation, ISO 9001, Persistence and Tenacity, Problem Solving, Process Oriented, Quality Auditing, Quality Control (QC), Quality Control Testing, Quality Standards, Quality Systems Documentation, Report Writing, Technologically Savvy