验证清洗专员
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：2014-03-05
- 工作地点：张家港
- 招聘人数：1
- 工作经验：一年以上
- 学历要求：本科
- 职位月薪：面议
- 职位类别：认证工程师/审核员
职位描述
岗位职责：
一、项目建设阶段
1、负责组织协调所有与设备验证相关的事宜；
2、与相关部门协作，完善设备验证系统；
3、监督和检查设备验证过程，严格确保设备按照批准的VMP进行；
4、协调所有工艺、设备验证相关事宜，检查并放行验证后设备；
5、审核设备验证方案及验证相关文件；
6、建立一个完整的验证文件存档体系；
二、项目生产阶段
1、负责组织协调所有与清洗相关的事宜，保证GMP要求下的设备清洗按时按质地完成；
2、与相关部门协作，建立一个完整的清洗管理与文件系统；
3、监督和检查设备清洗过程，严格确保设备按照批准的清洗SOP进行操作；
4、协调所有工艺设备清洗相关事宜，检查并放行生产后清洗设备；
5、审核设备清洗方案及清洗相关文件；
6、建立一个完整的清洗管理与文件存档体系；
7、完成上级领导安排的其他任务。
联系地址：江苏省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