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3-4年经验 -
本科 -
招1人 -
01-02 发布
- 五险一金
- 免费班车
- 绩效奖金
- 年终奖金
- 专业培训
- 定期体检
- 免费公寓
职位描述
1. Work directly under the direction of the QC supervisor.由QC主管直接安排工作。2. Prepare and complete QC personnel qualification and ensure personnel OJT is completed per position requirements. Undertake test method execution proficiency testing of QC personnel,operational procedures for equipment and external training coordination.准备并完成QC人员确认，并确保每个人按岗位要求都已完成在职培训。测试QC人员执行检测方法熟练度，完成设备操作程序和外部培训协调等工作。3. Review and maintain QC Chemistry SOPs.审核并维护QC化学标准操作程序。4. Participate in the Monthly Quality Organization and Operations Organization Meeting.参加每月的质量组织和操作组织会议。5. As required participate in the Quarterly Management Review Meeting.按要求参加季度管理审核会议。6. Support equipment qualification / validation/ testing.帮助做设备确认，验证和测试。7. Conduct development test method and validation.组织开发测试方法和验证。8. Coordinate with laboratory support for cleaning validation.与化验室协调，帮助做清洁验证。9. Coordinate QC Chemistry Stability Program including, stability studies, protocol assembly,reports, and projections/trendings.协调做QC化学稳定性项目，包括稳定研究，方案议会，报告和规划/趋势。10. Maintain the QC Chemistry stability test records.维护QC化学稳定测试记录。11. Provide support to laboratory investigations and complaints.对化验室调查与投诉提供支持。12. Test method review and approval.测试方法的审核与审批。13. Create and provide support for Material Specifications to determine suitability of the testing.为材料细则提供编写支持，判定测试的适用性。14. Lead in the research and development of new product and responsible for establishing new testing methods as well as qualifying and validating laboratory test methods.参与新产品的研发，负责新检验方法的建立及方法学的确认与验证。15. Responsible for maintaining and using the precision instruments and equipment in the laboratory.负责维护并使用实验室内的精密仪器和设备。16. Take part in product annual quality review analysis, and provide supporting statistical data.参加产品年度质量审核分析，并提供统计数据支持。17. Responsible for chemistry, microbiology and boiler room laboratory weekly and monthly safety inspection.负责理化、微生物、锅炉房实验室的周、月的安全检查。18. Perform other duties as assigned by supervisor in time.及时完成主管分配的其他工作 职能类别： 生物工程/生物制药
联系方式
海林市海林经济开发区东旭路7号
公司信息
公司总部位于美国加利福尼亚州圣地亚哥，生产工厂位于中国东北部风景优美的黑龙江省。基纳瑞克斯提供包括技术转移、工艺开发、放大实验、设备/工艺验证，配液、灌装、冻干、检验、完整性检测、贴标签及装盒等的整套服务，符合美国食药监局、欧洲药品管理局、中国食药监局及日本法规机构的要求。With our corporate headquarters located in San Diego, California, USA and our manufacturing facility located in the scenic Heilongjiang Province in the north eastern part of China OncoGenerix offers a fully integrated suite of services including technical transfer, process development, scale-up, equipment / process validation, formulation, filling, lyophilization, inspection, integrity testing, labeling and cartoning meeting the requirements of the US FDA, EMA, CFDA & Japan Regulatory
