北京诺诚健华医药科技有限公司招聘质量工程师qa

主要职能：

Key Objectives/Deliverables：

1.       GMP质量管理体系相关文件的起草，审核。

Drafting and reviewing relevant documents of GMP   quality management system.

2.       大分子研发质量管理体系相关文件起草、审核。研发记录本收发控制、研发质量相关工作的执行、支持和配合。

Draft and review documents   related to quality management system of macromolecular R&D. R & D   record sending and receiving control, R & D quality related work   implementation, support and cooperation.

3.       Veeva文件管理系统和培训系统日常操作和维护。

Daily operation and maintenance of Veeva document   management system and training system.

4.       GMP记录日常收发管理工作。

GMP records the daily receipt and delivery management.

5.       大分子项目IND和BLA申报QC相关部分的支持。

Support   related parts of IND and BLA declaration QC for macromolecular projects.

6.       QC OOS审核跟踪，台账管理。

QC OOS audit and tracking, ledger management.

7.       QC相关记录的审核、日常合规管控。

QC related record review, daily compliance control.

8.       供应商审计、相关资质资料收集，供应商档案建立。

Supplier audit, related qualification data collection,   supplier file establishment.

9.       对供应商进行定期考核和评估，保证供应商持续符合要求。

Conduct regular assessment and evaluation of suppliers   to ensure that suppliers continue to meet requirements.

10.   物料放行管理。

Material release management.

11.     参与委托生产、委托检验管理。

Participate in the management of commissioned   production and commissioned inspection.

12.     参与公司内部自检和外部审计。

Participate in internal self-inspection and external   audit of the company.

13.     领导安排的其他工作。

Other work assigned by the leader.

岗位要求：

Basic Requirements:

1.本科以上学历，药学，化学，微生物学，生物学或相关专业。

Bachelor or above degree in Pharmaceutical, Chemical, Microbiological, Biological or related field.

2. 有大分子QC检测工作经验，有活性检测经验者优先考虑。

QC working experience in macromolecule detection, experience in activity detection is preferred.

3.熟悉中美大分子质量控制检测相关法规规定。

Familiar with the relevant regulations and regulations of Chinese and American macromolecule quality control testing.

4..良好的团队合作精神，以及较强的沟通协调能力。较强的人际交流能力，特别是在有不同意见的时候，能够与不同部门，不同级别的同事建立合作关系。

Good team spirit and strong communication and collaboration skills. Strong interpersonal skills, especially in conflict situations. Ability to establish relationships with colleagues in different departments and at different levels

5.良好的英语读写能力.

Good English reading and writing skills.