QA文件管理员
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：2014-07-16
- 工作地点：张家港
- 招聘人数：1
- 学历要求：本科
- 职位月薪：面议
- 职位类别：其他
职位描述
职位描述：
1、部门日常行政工作，例如部门组织活动，部门文员工作，部门劳动保护用品统计、发放等；
2、文件系统的维护，包括文件编号（包括验证文件）的给定，电子版文件归档，发放已生效文件给相关部门（培训完成后），文件定期的复审工作，维护和更新文件目录以及word版文件；
3、检查质量相关的文件管理符合GMP要求，督促各部门记录的销毁工作；
4、汇总和协调变更申请以及跟进后续任务完成；
5、起草年度内审计划，并组织和协调内部审计，以及内部审计发现问题的跟进；
6、组织和协调外部（官方和客户）审计并跟进由此产生的CAPA；
7、负责管理、监督、检查GMP培训，包括起草GMP年度培训计划和总结；
8、对新员工进行GMP培训，包括GMP强化培训；
9、组织协调客户投拆和后续跟踪；
10、协调退换货处理；
11、负责投诉和退化季度、年度统计分析；
12、所有外来外发文件的归档；
13、负责搜集整理国家有关质量法规、政策及信息；
14、负责收集各类补充申请的注册文件工作；
15、负责收集许可证、认证、及再认证的文件管理工作；
16、QA经理安排的其他任务。
任职资格：
1、本科及以上学历，化工类或制药类相关专业；
2、英语CET-4；
3、性格活泼开朗。
联系地址：江苏省苏州张家港市扬子江国际化工园区长江东路528号
联系电话：0512－58723488
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