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QC专员-微生物 QC specialist -Microbiology Analyst

工作地点:无锡         所属类型:GCS-Formulation         发布时间:2020-06-17

岗位描述:

1. 根据SOP或者药典方法检测原辅料、包装材料、成品、和半成品中微生物限度,无菌检查以及内毒素检查;

Execute Microbiology limit test, sterility test and Endotoxin test of raw materials, packing materials, semi-finished product and finished product according to SOP or Pharmacopeia;

2. 执行公用系统、关键生产设备和产品工艺验证、清洁验证等验证过程中涉及到的微生物测试;

Perform related microbiological test during the validation of GMP system, critical manufacturing equipment and process, and cleaning validation;

3. 配合管理微生物实验室设备、仪器、培养基、菌种等;

Cooperate in management of equipment, instruments, culture media, and bacteria in microbiology lab;

4. 协助样品管理员或取样人员进行微生物检测的取样、留样;

Assist sample manager or sampling personnel with sampling and retention for microbiological test;

5. 配合纯化水取样及环境监测;

Cooperate to PW sampling and environment monitoring;

6. 配合实施微生物测试所用检验仪器的确认验证、维护、校验;

Cooperate to implement validation, maintenance, and calibration of microbiological testing instruments;

7. 负责微生物测试实验数据收集、处理,以及报告的书写;

Responsible for collecting and interpreting microbiological testing data, and report writing;

8. 起草或升级微生物检测相关文件,参与OOS调查,配合质量体系的优化;

Draft or update microbiological test related documents, participate OOS investigation, and input to optimize quality system;

9. 领导安排的其他工作。

Other work assigned.

任职资格:

一、 学历要求 / Diploma :

药学相关专业,大专以上学历

College degree in Pharmacy or related major.

二、 语言要求 / Language :

英语流利

Fluent in English

三、 工作经验 / Experience :

三年及以上微生物GMP检测相关经验

Minimum 3 years of relevant experience in a GMP environment for

Microbiology test.

四、 技术技能 / Technology and Skills

1.全面了解GMP操作规范以及数据完整性

Thorough understanding of GMP guidelines and data integrity.

2. 微生物培养及检测。

Microbiology culture and test.

3.无菌检测和内毒素检查。

Sterility test and Endotoxin test.

4.纯化水取样及检测。

PW sampling and testing

5.洁净区环境监测。

Cleanroom environment monitoring.

五、 个人品质/Personality

1.具有良好的学习,协调及沟通能力

Fast learning, cooperating, and communicating capability

2.具有良好的抗压能力,数据导向,及灵活性

Pressure tolerance, data orientation, and flexibility