DS原液QA专员(J19397)

• 负责临床和商业化原液生产现场质量监督，包括不限于生产步骤关键质量控制点，厂房设施、虫害控制、关键物料信息、物料状态确认，物料平衡和不合格品控制，对于生产车间任何异常提供质量评估协助；

Responsible for on-site quality supervision of clinical and commercial drug substance production, including but not limited to key quality control points in production steps, plant facilities, pest control, critical material information, material status confirmation, material balance and nonconforming product control, assist in quality assessment of any abnormalities in the production plant.

• 根据生产要求完成细胞领用监控并负责原液生产清场确认；

According to the production requirements to monitoring the use of cell bank，and responsible for the clearance confirmation of the DS production workshop

• 审阅生产类相关SOP、空白批记录，参与原液车间验证和偏差&变更活动质量监督；

Review SOP, blank batch record, participate in quality supervision of validation and deviation& change activities in DS workshop.

• 负责原液产品（自产、委托及受托产品）的放行审核，包括不限于批记录和批检验报告(包括批检验、中控、UPB)的审阅、原液产品批放行包的整理、每批关联的偏差&变更的梳理，确保原液放行符合注册标准和GMP要求；

Responsible for the release review of DS product (self-produced, commissioned and contract products), including but not limited to the review of batch records and CoA (including DS product , in-process testing and UPB testing), sorting out the batch release package of DS product, and sorting out the related deviations and changes of each batch to ensure that the release of the DS product meets the registration standards and GMP requirements;

• 支持偏差调查、变更风险评估，产品投诉和不良反应调查等；

Support for the deviation &change risk assessment, product complaints and adverse reaction investigations, etc.

• 支持公司的内审、集团检查、客户审计和官方检查，以及CMO审计；

Support the internal audit, Fosun corporate audit, Client audit and Authority Inspection as well as CMO audit.

• 完成上级安排的其他工作；

Complete other work assigned by superior.

• 在部门工作中遵守环保，健康和安全的法规要求。

Comply with environmental, health and safety regulations in routine work.

• 生物，生物化学，生物制药或者相关专业本科及以上学历，至少5年制药企业工作经验，了解生物制品生产现场质量监督和放行流程。

Bachelor degree or above in biology, biochemistry, biopharmaceutical or related major. At least 5 years working experience in pharmaceutical enterprises, aware of workshop floor quality supervision and release process of biological products.

• 具备生物制药项目经验的生物、生物制药相关专业的应届硕士研究生也符合任职要求。

Fresh graduate students in biology and biopharmaceutical related majors with biopharmaceutical project experience also meet the job requirements.

• 熟悉国内外GMP法规要求。

Be familiar with GMP regulations.

• 掌握常用的办公软件，及良好的英语读写能力。

Good command of office software, fluent English.

• 认真负责，结果导向，沟通能力强，团队合作意识佳，有较强的发现问题和解决问题的能力。

Accountability, results-driven, good communication skills, good team work, strong problem solving and trouble shooting.