药物分析主管
昆山龙灯瑞迪制药有限公司
- 公司规模:150-500人
- 公司性质:外资(非欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2017-07-09
- 工作地点:昆山
- 招聘人数:1人
- 工作经验:5-7年经验
- 学历要求:本科
- 语言要求:英语 良好
- 职位月薪:7-9千/月
- 职位类别:医药技术研发人员 化学分析测试员
职位描述
职位描述:
1) Conduct analytical support for Chemical drug and Generic drug development.
新药和仿制药研发提供分析支持
2) Conduct analytical methods development and quality research studies for pre-formulation samples, in-process samples, trial batches samples and formulations.
各类制剂产品分析方法开发和质量研究
3) Take part in in-vitro dissolution profile protocol preparation for GEA drugs.
参与质量和疗效一致性评价产品体外溶出曲线方案的制定
4) Take part in registration dossier preparation related to quality parts for domestic and imported new drug.
参与国产与进口新产品质量部分注册资料的撰写
5) Make sure the fully correctness of registration dossier translation for the registration of imported drugs.
确保进口药品注册药学研究翻译资料的准确性
6) Make sure the fully correctness of the original testing records.
确保原始检验记录的完全准确性
7) Manager various lab compliance works such as instruments validation and qualification, updating and making sure the correctness of history files etc.
管理实验室法规符合性工作,如仪器验证和确认、历史文件的更新并确保准确性等
8) Ensure that safety relevant issues are managed and lab sanitation keeping.
确保实验室安全与实验室卫生
9) Training of people in the areas of analysis, method development, documentation for formulations etc.
对部门内下属各级人员的培训
10) Maintenance and servicing of lab instruments (Including dealing with service engineers) in-order to reduce the down time.
实验室仪器设备的维护和维修
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1) Conduct analytical support for Chemical drug and Generic drug development.
新药和仿制药研发提供分析支持
2) Conduct analytical methods development and quality research studies for pre-formulation samples, in-process samples, trial batches samples and formulations.
各类制剂产品分析方法开发和质量研究
3) Take part in in-vitro dissolution profile protocol preparation for GEA drugs.
参与质量和疗效一致性评价产品体外溶出曲线方案的制定
4) Take part in registration dossier preparation related to quality parts for domestic and imported new drug.
参与国产与进口新产品质量部分注册资料的撰写
5) Make sure the fully correctness of registration dossier translation for the registration of imported drugs.
确保进口药品注册药学研究翻译资料的准确性
6) Make sure the fully correctness of the original testing records.
确保原始检验记录的完全准确性
7) Manager various lab compliance works such as instruments validation and qualification, updating and making sure the correctness of history files etc.
管理实验室法规符合性工作,如仪器验证和确认、历史文件的更新并确保准确性等
8) Ensure that safety relevant issues are managed and lab sanitation keeping.
确保实验室安全与实验室卫生
9) Training of people in the areas of analysis, method development, documentation for formulations etc.
对部门内下属各级人员的培训
10) Maintenance and servicing of lab instruments (Including dealing with service engineers) in-order to reduce the down time.
实验室仪器设备的维护和维修
职能类别: 医药技术研发人员 化学分析测试员
公司介绍
昆山龙灯瑞迪制药有限公司是由加拿大龙灯集团与印度瑞迪博士制药有限公司及昆山双鹤制药有限公司三方合资的一高新技术制药企业,公司主要生产经营医药原料及制剂产品。“引导健康新生活”是公司的核心目标,我们立志为人类健康事业做出应有的贡献。公司诚邀各界有识之士加盟“龙灯瑞迪”,共同创造美好未来。
联系方式
- 公司地址:广州增城