Scientist, Quality Control 质量控制科学家(原辅料/包材)
主要职责:

1. Conduct related daily   testing and test method development, such as endotoxin testing, TOC, Conductivity   test,HPLC test;

执行日常的相关测试和检测方法的开发,如细菌内毒素检测,总有机碳,电导率测试,HPLC 测试等;

2. Prepare test reports to support raw material/ product/   plant facility and other related material release;

准备支持原料、产品、厂房设施以及其他相关物料放行的相关报告;

3. Responsible for out test of raw material, package material;   

负责原辅料包材相关的外部测试;

4. Follow new project and strategy,   develop the new analysis methods and technology;   

结合公司项目从事新的检测方法和技术的开发工作;

5. Support to conduct cleanroom routine environmental   monitoring;

协助执行洁净区域的日常环境监测;

6. All related lab activities must meet regulation   requirements, like GMP, GLP; 

所有相关的实验室行为必须符合相关法规要求,如GMP,GLP ;

7. Draft all QC related SOPs,   including test SOP, management SOP, and update these SOPs basing on the   validation results or trend assay results or regulation;  

编写所有QC 相关的SOP,包括测试SOP,管理SOP,并根据验证结果或者趋势分析结果或法规及时更新相关SOP;

8. Order and maintain the consumables and reagents used in QC   testing;   

采购并管理测试所需的试剂耗材;

9. Operate QC equipment, cooperate   with relevant departments to conduct the equipment calibration and   maintenance timely;

使用QC相关仪器,和相关部门合作及时实施仪器的校验和维护;

10. Cooperate with other department to conduct related   validations, draft protocols, perform the procedures, analyze and report the   results. Participate in related deviation/OOS investigations, timely review the   abnormal cases;

和其他部门合作进行相关的验证工作,编制方案,实施检测,分析并汇报结果,参与相关的偏差/OOS调查,及时回顾异常情况;

11. Assist QC manager to complete   other work if needed.

如需要,协助QC经理完成其他相关工作。

任职要求:

1. BS degree BS degree in   biochemistry, chemistry or a related discipline with 2-3 years of QC relevant   experience in vaccine/bio-pharmaceutical industry, or MS in related   discipline with at least one years of relevant work experience; 

生物化学、化学或其他相关领域学士或硕士学位,7年以上疫苗、生物制药、无菌化药(如大输液)等行业QC相关工作经验;

2. Knowledge of standard requirements for raw material, package   material, product testing as stated by GB, CP, GMP;

具有国标、中国药典和GMP等法规关于原辅料包材成品等检测知识;

3. Familiar with related test equipment, like PTS, pH, HPLC, UV,   FTIR, HPLC;

熟悉相应的测试仪器设备,如PTS、pH计、紫外、红外、气相色谱等;

4. Working   knowledge and hands-on technical skills of lab/third party of test operations   and testing methods in relevant industry, such as endotoxin testing, TOC,   Conductivity test, identification; 

有相关工业领域实验室或者第三方检测机构实操经验,如细菌内毒素检测,总有机碳,电导率测试,鉴别;

5. Ability   to work effectively in QC team. Good written, interpersonal and communication   skills required;

具有在QC团队高效工作的能力。良好的写作、团队合作及沟通技巧;

6. Good communication skills in English and Chinese, fluent in   speaking, writing and reading in both languages.

良好的英语和中文沟通能力,能流利地说、写、读这两种语言。


招聘人数:2
联系方式:
human_resources@fosunkitebio.com