天津 [切换城市] 天津招聘天津质量管理/安全防护招聘天津质量管理/测试工程师(QA/QC工程师)招聘

Senior QA Specialist

杰科(天津)生物医药有限公司

  • 公司规模:50-150人
  • 公司性质:合资
  • 公司行业:制药/生物工程

职位信息

  • 发布日期:2020-03-19
  • 工作地点:天津-滨海新区
  • 招聘人数:1人
  • 工作经验:本科
  • 学历要求:招1人
  • 语言要求:不限
  • 职位类别:质量管理/测试工程师(QA/QC工程师)

职位描述

Job Description:
1. Work as the quality partner for production department. Generally responsible for the GMP compliance in the production department.
2. Review and approve process validation documents such as protocols, test records and reports.
3. Review and approve all SOPs in manufacturing departments and other appropriate quality related documents.
4. Make sure the operation compliance in the production department.
5. Audit and train the production team for the GMP compliance for manufacturing activities.
6. Review production batch manufacturing record and environment monitor record for the production area.
7. Work for the products release.
8. Deviation investigation and control.
9. Change request management.
10. Manage the CAPA actions.
11. Conduct the annual product quality review.
12. Review and approve the critical equipment maintenance and calibration plan and records.
13. Review and release raw materials, intermediates, packaging and labelling materials for production purpose.
14. Monitoring the quality KPIs.
15. Any other works designated by the company.

Job Requirements:
1. At least 10 years quality experiences in pharmaceutical industry, international biopharma company preferred.
2. Work experience with sterile drug product preferred.
3. University education with relevant majors such as pharmacy, chemistry etc. Master Degree Preferred.
4. Fluent written and spoken English.
5. A Good Team Member.

公司介绍

  杰科生物成立于2015年,公司坐落于天津滨海新区中新生态城。

  杰科生物产业定位于高端生物医药,产品涵盖单克隆抗体、重组蛋白、溶瘤病毒、免疫毒素、疫苗等。依托于我们可持续的强大创新研发实力、备受业界推崇的设备设施配置、遵循GMP的全过程管理体系以及最重要的——不断壮大的优秀人才团队,我们从研发、生产到上市,覆盖生物医药产业全链条。

  杰科生物致力于研发生产创新医药,在满足自身发展的同时,我们积极面向全球客户展开共赢合作,为客户定制和提供优质产品和增值服务,乃至完整的解决方案。

联系方式

  • 公司地址:中新生态城中滨大道2633号 (邮编:300467)