体外诊断试剂生产负责人
安倍医疗器械贸易(上海)有限公司
- 公司规模:50-150人
- 公司性质:外资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2015-05-22
- 工作地点:上海-浦东新区
- 招聘人数:1
- 学历要求:本科
- 语言要求:英语熟练
- 职位月薪:面议
- 职位类别:项目总监
职位描述
Position Summary:
Supervises Rapid Diagnostics’ production team and manages all facets of the daily production and distribution flow. Reporting to the production supervisor are the production coordinator, assembly supervisor, and production chemist.
Detailed responsibilities include but are not limited to:
Production Department Management
1. Directs all manufacturing activities and proper scheduling.
2. Ensures that Rapid Diagnostics’ finished goods are produced on schedule following GMP and ISO procedures.
3. Oversees processes assuring that batch records follow cGDP preserving good data collection and documentation.
4. Ensures that adequate raw material inventory is available to complete scheduled and emergency production.
5. Ensures that Diagnostics Division production equipment is properly maintained.
6. Ensures GMP regulation implementation within the Production Department.
7. Reviews and approves new standard operating procedures.
8. Provides administrative leadership in selecting, organizing, training and directing personnel in job assignments.
9. Ensures professional development opportunities for staff.
New Product Validation Program
1. Reviews and approves the validation all new manufacturing processes.
2. Ensures compatibility with existing equipment.
3. Implements new product standard operating procedures.
Qualifications & Requirements:
? 1-3 years medical device production lead experience
? BA/BS Science (Chemistry, Biology), Engineering preferred.
? Experience with POCT and lateral flow medical devices preferred.
? Good Communication and Interpersonal Skills.
? Good Computer Skills (MS Word, Excel, PowerPoint and Outlook, ERP systems, Adobe Reader, Google Programs, Email, etc.).
? Must be able to lift 50 lbs, bend, stretch, stand for extended periods of time, climb stairs, reach, twist, sit, walk, and/or run.
Supervises Rapid Diagnostics’ production team and manages all facets of the daily production and distribution flow. Reporting to the production supervisor are the production coordinator, assembly supervisor, and production chemist.
Detailed responsibilities include but are not limited to:
Production Department Management
1. Directs all manufacturing activities and proper scheduling.
2. Ensures that Rapid Diagnostics’ finished goods are produced on schedule following GMP and ISO procedures.
3. Oversees processes assuring that batch records follow cGDP preserving good data collection and documentation.
4. Ensures that adequate raw material inventory is available to complete scheduled and emergency production.
5. Ensures that Diagnostics Division production equipment is properly maintained.
6. Ensures GMP regulation implementation within the Production Department.
7. Reviews and approves new standard operating procedures.
8. Provides administrative leadership in selecting, organizing, training and directing personnel in job assignments.
9. Ensures professional development opportunities for staff.
New Product Validation Program
1. Reviews and approves the validation all new manufacturing processes.
2. Ensures compatibility with existing equipment.
3. Implements new product standard operating procedures.
Qualifications & Requirements:
? 1-3 years medical device production lead experience
? BA/BS Science (Chemistry, Biology), Engineering preferred.
? Experience with POCT and lateral flow medical devices preferred.
? Good Communication and Interpersonal Skills.
? Good Computer Skills (MS Word, Excel, PowerPoint and Outlook, ERP systems, Adobe Reader, Google Programs, Email, etc.).
? Must be able to lift 50 lbs, bend, stretch, stand for extended periods of time, climb stairs, reach, twist, sit, walk, and/or run.
公司介绍
MP Biomedicals是全球少数能够全面提供生命科学、精细化学及临床诊断类产品的公司之一。目前生产和销售的产品超过5.5万种,在生命科学及体外诊断领域品牌认可度高,主要产品已通过欧盟CE、中国CFDA、美国FDA等卫生监管部门的认证。
经过50多年的发展,MP已经形成了布局全球的销售网络和渠道。MP 总部位于美国加利福尼亚州,在中国、新加坡、澳大利亚、法国等全球14个国家设有16家子公司。2016 年,MP被中节能万润股份有限公司全资收购,成为旗下子公司。
生命科学业务主要产品包括分子生物学产品、细胞生物学、免疫化学产品、生物化学产品以及精细化学品,主要用于基因组学、蛋白质组学、代谢组学、药物开发、食品安全检测及科学探索的其他领域
体外诊断业务主要产品包括***诊断试剂、快速诊断试剂、免疫诊断试剂及配套仪器,主要用于艾滋病、各型肝炎、癌症、心脑血管疾病、登革热等疾病的诊断及毒品滥用、内分泌水平的检测
经过50多年的发展,MP已经形成了布局全球的销售网络和渠道。MP 总部位于美国加利福尼亚州,在中国、新加坡、澳大利亚、法国等全球14个国家设有16家子公司。2016 年,MP被中节能万润股份有限公司全资收购,成为旗下子公司。
生命科学业务主要产品包括分子生物学产品、细胞生物学、免疫化学产品、生物化学产品以及精细化学品,主要用于基因组学、蛋白质组学、代谢组学、药物开发、食品安全检测及科学探索的其他领域
体外诊断业务主要产品包括***诊断试剂、快速诊断试剂、免疫诊断试剂及配套仪器,主要用于艾滋病、各型肝炎、癌症、心脑血管疾病、登革热等疾病的诊断及毒品滥用、内分泌水平的检测
联系方式
- 公司地址:北京海淀区首体南路6号新世纪日航饭店写字楼