QA Engineer/Supervisor

公司部门: 北京诺诚






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.



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

2. 有文件起草的相关经验。

Relevant experience in document drafting.


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


At least 3 years QC working experience in macromolecule detection, experience in activity detection is preferred.


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


Good English reading and writing skills.