现场QA
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：2017-07-14
- 工作地点：张家港
- 招聘人数：1
- 工作经验：二年以上
- 学历要求：本科
- 职位月薪：面议
- 职位类别：质量管理/测试工程师(QA/QC工程师)
职位描述
岗位描述：
1、负责车间生产全过程的质量监督管理工作；
2、负责对原料、中间体、包装材料，工艺用水和环境监控（温湿度，压差）数据的管理符合规定；
3、负责监督、车间现场，整齐有序，使操作间，物料，设备等状态符合规定；
4、负责要求操作员按相关规定填写批生产记录；
5、负责审核及调查与产品质量相关的偏差处理和变更申请；
6、负责帮助车间主管组织相关人员起草修订车间相关GMP文件，并组织实施；
7、负责监督车间全体人员认真执行各项质量管理制度、工艺卫生管理制度和清场制度，签发清场合格证；
8、负责监控GMP培训；
9、QA高级经理安排的其他任务。
任职资格：
1、本科以上学历，制药或化工相关专业；
2、至少2年以上制药行业QA工作经验，具有成功的FDA、EMEA审计经验者优先；
3、英语CET-4或以上，良好的听说读写能力；
4、沟通能力强，能坚持原则。具有良好的团队合作意识。
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