职位描述:

1. 质量管理体系建立，质量保证相关文件的起草，审核。

Establishment of quality management system, drafting and reviewing relevant documents of quality assurance

2. 偏差管理，负责协调日常偏差调查和偏差审核，并定期汇报偏差管理体系运行情况；偏差台账管理。

Deviation management, responsible for coordinating daily deviation investigation and deviation audit, and reporting the operation of deviation management system regularly;Deviation ledger management.

3. 变更管理，负责协调日常变更发起管理，负责协调变更行动项的审核批准、实施和关闭的跟踪；变更台账管理。

Change management, responsible for coordinating daily change initiation management, and coordinating the review and approval, implementation and closing of change action items;Change ledger management

4. CAPA审核并跟踪管理，CAPA台账管理。

CAPA audit and tracking management, CAPA ledger management.

5. QC OOS审核跟踪，台账管理。

QC OOS audit and tracking, ledger management.

6. 供应商审计、相关资质资料收集，供应商档案建立及维护。

Supplier audit, related qualification data collection, establish and maintain supplier files.

7. 物料放行管理。

Material release management.

8. 参与委托生产管理，对CDMO进行审计和日常对接。

Participate in commissioned production management, audit and daily docking of CDMO.

9. 原液生产现场监督，相关批生产记录审核。有生物大分子现场监督经验。

Supervised the stock solution production site and reviewed relevant batch production records.Experience in field supervision of biomacromolecules.

10. 制剂生产现场监督，相关批记录审核。有无菌制剂现场监督和模拟罐装相关经验。

Supervised the preparation production site and reviewed the relevant batch records.Experience in sterile preparation field supervision and simulation canning.

11. 参与公司内部自检和外部审计。

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

12. 质量风险管理。

Quality risk management.

任职条件:

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.熟悉中国和美国药品监管的各项法规，包括生产，商业，运输等流程，要求有相关领域的实际工作经验。

Familiar with regulation requirement of NMPA FDA for drug, including manufacture , business and distribution process etc. also need actual working experience on related areas

3.3年以上外资或合资生物大分子企业相关工作经验，至少2年统管体系经验，经历0-1体系建立过程者优先。有大分子QC检验经验者择优。

At least 3 years of experience in pharmaceutical production and quality management International/ cooperative

biomacromolecule enterprises, At least 2 years experience in management system, Experience of 0-1 system establishment process is preferred.Experience in QC inspection of large molecules is preferred.

4.至少1年生物大分子原液和制剂现场监督经验，熟悉抗体原液和制剂生产工艺流程，有放行审核经验，熟悉无菌生产相关要求。

At least 1 year experience in field supervision of biological macromolecule stoste and preparation, familiar with production process of antibody stoste and preparation, experience in release review, familiar with related requirements of aseptic production.

5.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.较强的处理，调查以及解决问题能力

Strongly address, investigate and solve ability

6.良好的英语读写能力

Good English reading and writing skills