微生物主管
江苏恒盛药业有限公司
- 公司规模:150-500人
- 公司行业:制药/生物工程 石油/化工/矿产/地质
职位信息
- 发布日期:2013-12-17
- 工作地点:张家港
- 招聘人数:1
- 工作经验:三年以上
- 学历要求:本科
- 职位类别:生物工程/生物制药 质量管理/测试主管(QA/QC主管)
职位描述
职位概要:
负责所有环境监控样品的分析检验工作,包括纯化水系统、洁净间、氮气管道等,以及其化微生物检验工作。规范操作,提供准确可靠的分析数据与报告,确保微生物实验室正常有序运行。
岗位职责:
1、确保微生物实验室正常运作;
2、审批实验室所有检验记录,监控记录及报告;
3、实验室部分管理SOP、测试方法、记录表等文件的编写及所有文件的审批工作;
4、实验室OOS,DR调查及审批工作;
5、统筹协调EM工作;
6、实验室审计工作;
7、技术员的培训与评估;
8、技术员日常工作安排及绩效评估;
10、协助安全员的工作,督促组内成员进行规范、安全操作,保证实验室安全;
11、参与QC内部沟通协调工作。
任职资格:
1、本科及以上学历(或者中级专业职称或执业药师资格);
2、药学或相关专业;
3、至少三年环境、微生物检测的管理经验,接受过所生产产品相关的专业知识培训;
4、了解《药品生产质量管理规范》及国家相关法律法规,有较强的管理、协调能力,具备微生物学方面的专业知识。
负责所有环境监控样品的分析检验工作,包括纯化水系统、洁净间、氮气管道等,以及其化微生物检验工作。规范操作,提供准确可靠的分析数据与报告,确保微生物实验室正常有序运行。
岗位职责:
1、确保微生物实验室正常运作;
2、审批实验室所有检验记录,监控记录及报告;
3、实验室部分管理SOP、测试方法、记录表等文件的编写及所有文件的审批工作;
4、实验室OOS,DR调查及审批工作;
5、统筹协调EM工作;
6、实验室审计工作;
7、技术员的培训与评估;
8、技术员日常工作安排及绩效评估;
10、协助安全员的工作,督促组内成员进行规范、安全操作,保证实验室安全;
11、参与QC内部沟通协调工作。
任职资格:
1、本科及以上学历(或者中级专业职称或执业药师资格);
2、药学或相关专业;
3、至少三年环境、微生物检测的管理经验,接受过所生产产品相关的专业知识培训;
4、了解《药品生产质量管理规范》及国家相关法律法规,有较强的管理、协调能力,具备微生物学方面的专业知识。
公司介绍
江苏恒盛药业有限公司系江苏高科技股份制企业,投资方为(1)上海主板一上市公司及(2)南京一大型投资公司等,拥有精通国际国内医药业务的国际化及本土化的管理团队,现有员工300余人,并快速增长发展转型中。公司现有业务年销售额近3亿元,正实施新型生物医药投资项目,并推进综合制药采购、技术、cGMP制造、准入法规及国内外市场的一体化原料药和制剂的具备国际水准的业务转型,对呼吸道疾病及代谢性疾病治疗药品的业务进行创新及价值整合。业务范围包含苏州张家港市扬子江国际工业园区的制造及研发放大基地,上海徐汇区聚科高科技园区的商务研发中心,以及正并购中的其它医药业务。
Jiangsu Hansyn Pharmaceutical Co., Ltd is a high-tech private pharmaceutical organization in Jiangsu, with share holders of (1) a Shanghai stock exchange listed company, (2) a fund-management & investment company in Nanjing, and others. Its assets include a manufacturing site in Zhangjiagang International Industrial Park, and a R&D and business center in Juke High-tech Park in Xuhui district, Shanghai. It owns a core management team from both overseas returnees and local talents in pharmaceutical industry, with a staff of over 300 currently and under rapid expansion. Its existing revenue is about RMB 300M, with new investments of manufacturing + R&D for active pharmaceutical ingredients is being executed, and possible acquisitions ongoing. The business focus is to provide the optimum integrated services and products for Regulated Sourcing, Contract Research & Development (CRO) and cGMP Custom Manufacturing (CMO) to pharmaceutical industry. With its experience and expertise in pharmaceutical and chemistry, the company is striving to offer value synergies and innovations to customers via sustainable partnership in key therapeutic areas including respiratory, metabolism and diabetes.
http://www.hspharm.cn/
Jiangsu Hansyn Pharmaceutical Co., Ltd is a high-tech private pharmaceutical organization in Jiangsu, with share holders of (1) a Shanghai stock exchange listed company, (2) a fund-management & investment company in Nanjing, and others. Its assets include a manufacturing site in Zhangjiagang International Industrial Park, and a R&D and business center in Juke High-tech Park in Xuhui district, Shanghai. It owns a core management team from both overseas returnees and local talents in pharmaceutical industry, with a staff of over 300 currently and under rapid expansion. Its existing revenue is about RMB 300M, with new investments of manufacturing + R&D for active pharmaceutical ingredients is being executed, and possible acquisitions ongoing. The business focus is to provide the optimum integrated services and products for Regulated Sourcing, Contract Research & Development (CRO) and cGMP Custom Manufacturing (CMO) to pharmaceutical industry. With its experience and expertise in pharmaceutical and chemistry, the company is striving to offer value synergies and innovations to customers via sustainable partnership in key therapeutic areas including respiratory, metabolism and diabetes.
http://www.hspharm.cn/
联系方式
- 公司地址:上班地址:张家港市金港镇扬子江国际化工园区长江东路528号