高级验证主管
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:2017-08-12
- 工作地点:张家港
- 招聘人数:1
- 工作经验:三年以上
- 学历要求:大专
- 职位月薪:面议
- 职位类别:药品生产/质量管理
职位描述
岗位职责:
1、QA经理的代理人,主要负责在验证方面事务;
2、全面负责验证方面的事务(除分析仪器和分析方法验证外);
3、维护验证体系(验证总计划,验证计划,SOP……);
4、对验证小组进行必要的培训;
5、最终批准确认文件;
6、审批验证当中的测试事故和工程变更;
7、组织和维护生产工艺验证;
8、组织和维护清洁工艺验证;
9、执行纯化水系统、氮气系统、压缩空气系统、洁净室和仓库的PQ;
10、审批实验设备和仪器的确认文件;
11、审批清洁及清洁验证相关文件;
12、审批计算机系统的验证文件;
13、评估验证相关的变更;
14、评估验证相关的偏差;
15、负责所属部分的HSE工作;
16、上级领导安排的其他任务。
任职资格:
1、大专及以上学历(或者中级专业职称或执业药师资格);
2、药学或相关专业;
3、至少三年从事制药企业验证实践经验;
4、熟悉《药品生产质量管理规范》及国家相关法律法规;
5、有较强的沟通能力,英语良好,听说读写流利;
6、能够独立应对官方和客户针对验证方面的审计。
1、QA经理的代理人,主要负责在验证方面事务;
2、全面负责验证方面的事务(除分析仪器和分析方法验证外);
3、维护验证体系(验证总计划,验证计划,SOP……);
4、对验证小组进行必要的培训;
5、最终批准确认文件;
6、审批验证当中的测试事故和工程变更;
7、组织和维护生产工艺验证;
8、组织和维护清洁工艺验证;
9、执行纯化水系统、氮气系统、压缩空气系统、洁净室和仓库的PQ;
10、审批实验设备和仪器的确认文件;
11、审批清洁及清洁验证相关文件;
12、审批计算机系统的验证文件;
13、评估验证相关的变更;
14、评估验证相关的偏差;
15、负责所属部分的HSE工作;
16、上级领导安排的其他任务。
任职资格:
1、大专及以上学历(或者中级专业职称或执业药师资格);
2、药学或相关专业;
3、至少三年从事制药企业验证实践经验;
4、熟悉《药品生产质量管理规范》及国家相关法律法规;
5、有较强的沟通能力,英语良好,听说读写流利;
6、能够独立应对官方和客户针对验证方面的审计。
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