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Director or Senior Director, Quality Assurance

发布时间:2017-07-18 
职位职能:  生物工程/生物制药  药品生产/质量管理

职位描述:
★    QA总监/高级总监
Director or Senior Director, Quality Assurance

Responsibilities:
The individual is responsible for quality management of the organization that developing and manufacturing biopharmaceutics including therapeutic monoclonal antibodies, fusion proteins, immunotoxins, viral vectors, cytokines and etc. using fermentation, cell culture, and purification manufacturing processes under GMP regulations. The individual will lead a department including auditors, QA engineers, GMP training, and GMP documentation. The individual will be responsible for establishing quality management system and hold international standard (US and EMA) for entire organization. Supporting regulatory affair department and Manufacturing department.

Request:
Minimum 10 years biopharmaceutical industrial experiences with related training in biological engineering, or biological sciences. Must have strong CGMP background in biologics. Previous leadership in QA department for biological manufacturing is required. Previous experiences in international biopharmaceutical industry is appreciated. Excellent communication skill both in Chinese and in English is required.

主要职责:
1.负责在GMP标准下使用发酵、细胞培养、纯化等制造工艺进行研发和生产的生物制剂{包括治疗性单克隆抗体、融合蛋白、抗毒素、病毒载体,细胞因子等)的质量管理。
2.负责带领部门团队,包括审计员、质量工程师、GMP培训人员、GMP文件编制人员。
3. 负责建立符合美国和欧盟标准的质量管理体系。
4. 负责支持和配合药品报批部门及生产部门的工作。

具体要求:
1.硕士以上学历,于生物工程或生物科学相关专业;在生物制药领域拥有10年以上的工作经验;
2.具有良好的生物制剂cGMP相关工作经验,精通cGMP相关知识及要求标准;
3.拥有生物制药企业QA部门的管理经验。
4.拥有国际生物制药企业相关工作经验者优先;具有流利的英语口语和读写能力。

上班地址:
滨海新区中新生态城中天大道1620号研发大厦

杰科(天津)生物医药有限公司 pk10techchasse.com版权所有

地址:中国天津滨海新区中新天津生态城中天大道1620号研发大厦12层

技术支持:维程互联

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