QA技术员

4 days ago

Wuxi, China Pfizer Full time

目的

负责按照规程对生产全过程进行质量保证检查，进行生产过程控制的取样，以保证所有生产过程控制全部按照工厂规程进行。执行对批包装生产文件和过程控制记录文件进行审核，保证其准确无误。执行包装材料的取样和检验，并完成包装材料的及时发放。协助QA主管完成GMP文件或记录的管理。完成QA主管授予的相关工作。

Purpose

To be responsible for in-process inspection and sampling to ensure the whole production process control to be in compliance with plant procedures. To review batch packaging processing record and in-process control record to ensure its accuracy. To perform the sampling and inspection of packaging materials and ensure packaging materials can be released in time. Cooperate with QA Supervisor to management the GMP documents and records. To complete other associated job assigned by QA Supervisor.

职责范围

过程控制：

负责按照规程对生产全过程进行质量保证检查，进行生产过程控制的取样，以保证所有生产过程控制全部按照工厂规程进行。

执行对批包装生产文件和过程控制记录文件进行审核，保证其准确无误。 包材检验：

对包装材料进行取样和检查，协调及保证包材的及时发放。

协助完成GMP文件或记录的管理。

完成QA技术员及QA主管授予的相关工作。

Responsibility scope

A.In-process control:

Responsible for in-process inspection of manufacturing process and in-process sampling to ensure that production activity compliance with the SOPs.

B.Document review: To review batch packaging processing record and in-process control record to ensure its accuracy.

C.Test of Packaging Materials:

To conduct sampling and testing of Packaging material, coordinating and ensuring timely releasing of packaging material.

D.Cooperate with QA to management the GMP documents and records.

Complete other related work assigned by QA Supervisor.

任职要求

教育程度/经验：中专及以上学历，药学/药物分析/化学分析/化学等相关专业；掌握辉瑞质量管理系统，国家GMP及相关药政法规。 特别知识：掌握辉瑞质量管理系统，国家GMP及相关药政法规。

Job requirements

Education Background/ Experience: Technical secondary school or above, related major of pharmacy, pharmaceutical analysis, analytical chemistry or chemistry etc. Special Knowledge: Master PQS(Pfizer Quality Standard), GMP and related regulations. To be cooperative and have sense of responsibility: Have capability of communication and training Skills：  Work Location Assignment: On Premise 技能：具有团队合作精神，工作责任心强；具有一定的沟通协调能力和培训能力。
 

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Quality Assurance and Control#LI-PFE

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