5 年以上跨国公司或CRO 的GCP QA的管理经验 是临床试验核查的现场主要应对人 质量事件处理的决策经验 较丰富的质量系统搭建经验 或3 年左右跨国公司或者CRO 的GCP QA 参与过核查或核查准备 参与质量事件处理经验 参与质量系统搭建经验

岗位职责

1.确保QA体系有效运行，质量体系健全和完善

2.审核批准生产质量文件（包括工艺验证和设备清洗验证）；确保文件的准确性和符合性

3.批准产品放行；确保放行审核的正确性

4.组织客户审计迎审、整改落实；确保质量审计顺利通过；及时对客户提出的缺陷，组织人员整改落实

5.不断优化流程，提高管理水平，提高工作质量和效率

6.营造学习型团队氛围，帮助员工提升和发展

Job Description:

Responsible for Quality Assurance (QA) programs and activities by coordinating with the company CEO; this includes drafting and reviewing relevant quality system documents, remediation or establishment of customer′s quality system, directing deviation, change control, product release and other QA systems, supplier and CMO GMP audits, developing and implementing validation systems and actual validation activities.

任职要求：

本科及以上学历，分子生物学、生物工程、药学、化学等相关专业背景；

5年以上制药行业工作经验

工作责任心强，做事严谨高效，具有良好的团队合作精神及与各方的沟通能力；

有良好的英语读写能力；

Job Requirement:

1、Bachelor and/or other advanced degree in Molecular Biology, Biological Engineering, Pharmacy, Chemistry or equivalent;

2、More than 5 years working experience in the pharmaceutical industry. Hands-on experience in MAb CMC, Quality is required;

3、Familiar with the China, European and American cGMP, ICH and other relevant laws and regulations, as well as regulatory registration processes;

4、Strong sense of responsibility, integrity, high precision work style and efficient management of multiple priorities;

5、A good team player with excellent communication and influencing abilities;

6、Excellent verbal and written English skills.

上班地址：中山西路999号华闻大厦