武汉招聘

  

Job Responsibilities/岗位职责

  

• Stability study administrator which in charge of stability protocol/report preparation and storage/management of stability sample

• 稳定性研究管理主要负责编写稳定性方案和报告，稳定性样品存储和管理。

• Sample administrator which mainly responsible for sample receipt/ storage/distribution/disposal, test report and CoA issuance

  样品管理主要负责样品接收，存储，分发和销毁，分析检测报告的出具。

• Act as QC point of contact to communicate and coordinate internally and externally to ensure all the QC related activities completed within the individual project timeline.

  QC部门项目联系人，负责内外沟通和协调，确保所有与QC相关的活动都在项目要求的时间线内如期完成。

• LIMS master data set up to ensure all the test report of RM and IPC/DS/DP can be issued timely.

       LIMS主数据建立以确保所有的原辅料/中间品/原液/制剂的检测报告可以及时出具。

 

Job Requirements/岗位要求

 

• Bachelor’s degree in chemistry/biologic/ with 3+ years’ experience in quality control systems in biopharmaceuticals.

  化学/生物专业本科毕业，至少三年生物医药行业QC工作经验。

• Thorough knowledge of GMP regulations and documentation.

  GMP法规和文件的深度理解。

• Understanding of the basic statistics required in QC data analysis.

  熟练掌握QC数据的统计分析。

• Excellent oral and written communication skills in Chinese and English.

  熟练的中文和英语写作以及口头沟通能力。                                

鼎康生物是一家领先的CDMO公司，可提供一站式的CMC解决方案，支持从早期药物开发到后期临床研究和商业化cGMP生产。鼎康引进了全球***模块化生物制药工厂Kubio；为客户开发的多个产品已经在全球20多个国家进行临床试验。在不久的将来，鼎康生物总产能将超过140,000L。我们承诺通过技术和生产创新，使全球患者都能负担得起具有国际标准的生物药物，提高治疗水平以改善人类健康。