Principal Duties and Responsibilities/主要职责（包括但不限于）

• 负责QA部门质量运营活动，包括起草和审核质量文件，建立或整改质量体系，指导偏差、变更、产品放行和其他的质量活动。

  Take a lead role in Quality Assurance (QA) programs and activities, these include drafting and reviewing relevant quality system documents, directing deviation, change control, product release and other QA systems operations.

• 负责生物药原液生产现场监管、批记录以及批生产相关记录审核，确保原液放行符合既定质量标准和GMP要求。

  Responsible for oversight on DS manufacturing, batch records review and related records review. Ensure release of DS conforms to required specification and GMP requirements.

• 负责对第三方公司进行审计，如C/DMO，CTO或者冷链服务商进行现场审计，出具审计报告。

  Responsible for audit of third-party company, these include C/DMO,CTO or Cold Chain Transportation Company, and issuing the audit report accordingly.

• 参与驾玉cGMP检测实验室质量体系的建立、维护和执行，并负责质检中心质量合规工作。

  Participate in the establishment, maintainance, and implementation quality system for the JADE cGMP Testing Laboratory. Assume responsibility for quality compliance in the QC testing facility(ies)

• 作为驾玉创业团队的一员，积极参与驾玉生物(CQO & QC)跨职能的业务开发活动。

  As a member of JADE entrepreneurial team, actively participated in business development activities cross functionally for Jade Biomedical (CQO & QC Testing).

Job Requirements/工作经验

• 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；

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

• 5年以上制药行业工作经验，其中生物制药单抗原液的经验不少于2年；

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

• 熟悉EU，US FDA，NMPA，ICH等相关法规，熟悉注册申报流程；

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

• 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；

  Strong sense of responsibility, integrity, high precision work style and efficient management of multiple priorities. A good team player with excellent communication and influencing abilities;

• 有良好的英语沟通读写能力；

Excellent verbal and written English skills.

上班地址：新平街腾飞创新园