南京招聘

  

• 负责GMP合规管理工作，确保公司质量方针及质量体系的有效运行；
  Responsible GMP compliance management to ensure that the effective operation of quality policy and quality system of company;

• 协助新厂质量体系建立，搭建质量管理框架并持续改进，如负责CAPA，偏差，质量回顾等生产现场相关体系的管理及维护。
  Support to develop a new plant quality system and construct a structure of quality management, ensure system continuously improvement, such as manage and maintain the process of CAPA, Deviation and Product Quality Review etc. which are related to on-spot production.

• 确保产品生产制造和检测过程符合法规和注册要求；
  Ensure GMP compliance and registration requirement in manufacturing process/analysis process.

• 现场缺陷分析和偏离处理。
  In process defective analysis and disposal of deviation.

• 协助其他部门发起并完成变更，并确保对产品质量有潜在影响的变更均被恰当评估与实施。
  Responsible for collaborating with each department to initiate and close Change Controls, with the precondition that all potential impacts of Change Control regarding to product quality have been evaluated.

• 领导安排的其他工作。

Working task which is arranged by direct supervisor.

工作要求Job Requirement

本科或以上学历，药学，生物学或化学专业 Bachelor or above degree in Pharmacy, Biology, Chemistry, etc     ？  

熟悉CFDA cGMP, EU cGMP、PIC/S cGMP及FDA cGMP的要求。 Familiar with the regulatory requirement of CFDA cGMP, EU cGMP, PIC/S cGMP and FDA cGMP. ？  

熟悉按照CFDA/FDA cGMP开展自查。 Familiar self-inspection according to CFDA/FDA cGMP ？  

具有较强的处理、分析和解决问题的能力。 ？   Strongly address, investigate and solve ability.

医药行业5年以上生物制药质量管理与监督经验。 ？   No less than 5 years experiences in pharmaceutical quality assurance  

英语水平良好，会熟练使用电脑 Good English and computer skill    

百济神州是一家立足于科学的全球性生物科技公司，专注于开发创新、可负担的药物，旨在为全球患者改善治疗效果，提高药物可及性。目前公司广泛的药物组合包括40多款临床候选药物。公司通过加强自主研发能力和合作，加速推进多元、创新的药物管线开发。我们致力于在2030年前为全球20多亿人全面改善药物可及性。百济神州在全球五大洲打造了一支超过8,000人的团队。