QC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：2014-08-18
- 工作地点：张家港
- 招聘人数：1
- 工作经验：三年以上
- 学历要求：硕士
- 职位月薪：面议
- 职位类别：质量管理/测试主管(QA/QC主管)
职位描述
职位描述：
1、全面负责分析方法的验证和转移工作，确保项目的顺利进行；
2、负责编写分析方法验证和转移的SOP，以及编写单独的验证方案和报告；
3、指导和监督完成相应的分析验证实验；对检验数据准确性、真实性负责；
4、负责生产QC－plan的制定，生效后负责检验员的检验工作技术培训；
5、负责清洗分析方法的开发、验证，并制定清洗QC－plan及对实验室人员进行培训；
6、负责跟踪项目分析过程中偏差（Deviation），超标（OOS）以及变更（Change）；
7、负责与其他部门就项目相关事务进行积极沟通，保证信息畅通；
8、参与实验室仪器、设备、容器的校准管理参及常用检验仪器设备的使用和保养工作；
9、参与组织制定和修订原辅料、包装材料、中间产品及成品的质量标准和检验操作规程；
10、监督检验操作，审核各类样品的检验原始记录，并负责检验数据的整理汇总，共趋势分析等所需；
11、协助化验室QA对检验结果AAR和OOS进行调查和分析，经QC经理批准后，安排复检，并将调查原因或复检结果反馈给化验室QA和QC经理；
12、领导安排的其他工作。
任职要求：
1、本科及以上学历，制药或化工类相关专业；
2、至少三年以上制药行业QC工作经验，其中一年以上QC主管经验；
3、具有分析方法验证经验者优先；
4、英语CET－6，具有良好的英语听说读写能力；
5、沟通能力强，能够坚持原则，具有较强的团队合作意识。
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