分析方法验证和转移主管
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：2013-06-18
- 工作地点：张家港
- 招聘人数：1
- 工作经验：五年以上
- 学历要求：硕士
- 职位类别：化学分析测试员
职位描述
岗位职责：
1、全面负责分析方法和验证和转移工作，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；
4、负责生产QC－plan的制定，生效后对实验室人员进行培训；
5、负责清洗分析方法的开发、验证，并制定清洗QC－Plan，生效后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（Chang）；
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、参与实验室仪器管理；
9、参与客户审计以及公司的内审；
10、参与QC内部沟通和协调工作；
11、领导安排的其他工作。
岗位要求：
1、硕士以上学历，制药或化工相关专业；
2、至少5年以上制药行业QC工作经验，具有分析方法验证经验者优先；
3、具有良好的英语听说读写能力；
4、具有一定的沟通能力，能够坚持原则，具有良好的团队合作意识。
联系地址：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