PGS-微生物分析师-无锡

Purpose 目的：

To be responsible for the microbiological test of raw materials, intermediate, finished products and inner package material. To perform the test for registration, method validation and the product stability tests. Be responsible for sampling and monitoring for the water system and compress gas system in the site. Be responsible for calibration of related instrument in microbiological laboratory. Be responsible for initial and maintenances, the related Standard Operating Procedure, test method. To instruct the new staff.

负责原辅材料、中间体产品、成品、半成品等的相关检验；注册检验；检验方法的验证，产品稳定性的考察；实施对工厂水系统、压缩气体等的取样和对仪器及设备的校验；实验室相关标准操作规程、检验方法的起草及维护；新员工的培训。

Responsibility scope 职责范围：

To perform microbiological related test of raw materials, intermediate, finished products and inner package material. And to be responsible for the original analysis result.

实施对原辅材料、中间体产品、成品、半成品等的微生物分析，并对检验原始数据负责。

To be responsible for the preparation of reagents, media, rinse fluid and so on. And to be responsible for the validity of reagents, media and rinse fluid.

负责准备或配制实验所用试剂、培养基、淋洗液等，并对所用试剂、培养基及淋洗液的有效性负责。

Responsible for the management of laboratory strains, passaging and storing strains according to requirements.

负责实验室菌种的管理，按照要求进行菌种传代与保存。

To perform method validation and product stability study.

方法验证，稳定性考察。

To be responsible for the usage, calibration, cleaning and maintenance of the instruments to make the instrument run effectively.

实验室仪器设备的使用、校验、清洁、维护、验证，使设备处于有效运行与管理之中。

To perform the sampling and monitoring of the water system,pure steam and compress gas system.

实施对工厂水系统、洁净蒸汽、压缩气体等的取样监测。

Be responsible for initial and maintenances the related Standard Operating Procedure, test method and assist in preparation of product quality and chemical test technical document. And to be responsible for organizing the preparation of technical documents related to quality or chemical test and the management and filing of those documents.

对实验室相关标准操作规程、检验方法的起草及维护，组织制备有关产品质量或微生物检验的技术文件，负责原始记录等的管理和归档。

To perform the test for registration and complaint investigation.

协助注册报批检验，配合投诉调查。

Train the new staff.

新员工的培训。

Stay in touch with Pfizer's technical team, participate in relevant technical forums, participate in relevant microbiology assessments, and maintain the scientific and advanced nature of laboratory work.

与辉瑞总部技术团队保持联系，参与相关技术论坛，参与相关微生物学的评估，保持实验室工作的科学性和先进性。

To carry out other works assigned by Quality Operation Manager or Quality Control Supervisor.

负责完成质量部经理或微生物实验室主管交办的其它工作。

Comply with Environment \Health\ Safety policy and regulation, and complete the Environment \Health\ Safety related work.

遵守公司有关环境健康安全的政策和规定，并完成环境健康安全相关工作。

Job requirements 任职要求：

Education Background/ Experience： College degree or above, major in pharmaceutical / bioengineering/biotechnology or other biological related work experience.

教育程度/经验：本科以上学历，药学/微生物学/生物工程/生物技术/其他生物相关专业或相关工作经验

Special Knowledge：Master Pfizer Quality Standards, Good Manufacturing Practices and related regulations.

特别知识：掌握辉瑞质量管理系统，国家GMP及相关药政法规。

Skills 技能要求：

Have good English and computer application ability. 具有良好的英语综合能力及计算机应用能力；

To be cooperative and have sense of responsibility. 具有团队合作精神，工作责任心强；

Have capability of communication and training. 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.

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