上海招聘

Version number: Version 1.0 for GSP/QA Operation Manager

Country: China

General

Job Title: Quality Assurance Manager

Department:

RA&QA

Operationally reports to

(the position, not the person name) Director of QA

Functionally reports to the position (the position, not the person name) QA team member

Job Purpose (State the overall objective of the position

1. Coordinate the executions about quality system and quality management activities of Drug Product and Medical Device distribution.

2. Responsible to manage all company SOPs, and follow up the SOPs training and effectiveness.

Major Accountabilities (Describe the main results of the job to be achieved

1. Follow up all GSP related activities. 跟踪跟GSP相关的活动：

1.1 Coordinate to supply chain or sales person to collect and maintain all vendor, customer and product information, and identify any gap before company sign the contracts with them.

协助供应链和销售人员收集和维护所有供货商、客户和产品的信息，在合同签订前，识别出不足。

1.2 Visual check all received product from vendors, and release them based on company SOPs.

目视检查所来自供应商的产品，并按照SOP放行产品。

1.3 Collect all queries or complaints from customer. Primarily review the information from the customer, and decide if the investigation is needed or not.

收集来自客户的所有查询和投诉，初步审核来自客户的信息，决定是否需要发起调查。

1.4 Manager the contractor for the activities of storage, transportation.

管理储存、运输相关的受托企业

1.5 Prepare the self-inspection plan on GSP quality system, draft the self-inspection report and submit to the authority every year.

准备GSP质量系统的自检计划，准备自检报告，并每年及时提交给官方。

1.6 Primary review any deviation from contractor and give the guideline how to investigate it, and follow up it.

初步检查来自合同商的偏差，并指导和跟踪调查

2. Coordinate and drive below activities related to GMP.

协助以下跟GMP相关的活动

北海康成（北京）医药科技有限公司正式成立于2012年6月，总部设立在中关村望京科技创业园区内。
北海康成致力于解决满足“三个需求”，即满足中国患者对高效药物的需求、中国药企关键技术、产品更新换代的需求、发达国家中小生物制药企业进入中国市场的需求。
北海康成通过技术转让、吸收和再创新对接世界最大的生命高科技医药产品线与全球增长最快、潜力最大的应用市场。公司引进、研发、上市的重点是中国和亚洲市场所急需的特效药物。北海康成已经与欧美创新型生物制药公司、研究机构开展多个抗癌药物领域的技术合作。公司注重临床后期新药开发，有针对性地获取尖端的或国内新药研发所急需的制剂和生产工艺方面的成果，通过再创新和技术转化研发上市拥有自主知识产权的医药产品。