非无菌项目QA(J24569)

主要职责包括：

the main responsibilities including

支持项目转移，审批项目相关文件，包括但不限于批记录母本、执行后批记录等，确保转移活动符合合全/客户和法规的要求。

Support project transfer and review the relevant documents, including but not limited to review MBR, EBR and so on. To ensure transfer activities in compliance with STA/client and regulatory requirements.

参与新产品引入评估，并批准共线风险评估报告。

Participate in new product introduction evaluation and approve co-line production risk assessment report .

批准项目物料清单。

approve related material list of the project.

按既定程序和标准放行原辅料，包装材料，中间产品，临床成品。

Release raw materials, packaging materials, intermediate products, clinical products according to established procedures and standards.

负责按照批准程序执行清洁确认/验证后的设备放行。

Responsible for the release of equipment after cleaning validation/verification in accordance with approved procedures.

支持生产过程中现场的质量相关工作。

Support for the relevant quality work during the production process.

审核项目相关的质量协议，根据需求起草质量协议工作流程，确保相关的生产和检测服务满足质量协议的要求。

Review the quality agreement related to the project, draft the quality agreement workflow according to the requirements, to ensure the related production and testing services meet the requirements of the quality agreements.

负责协调偏差，变更，客户质量投诉调查，确保纠正和预防措施的有效执行和记录。

Responsible for coordinating deviation, change, client quality complaint investigation, ensuring corrective and preventive actions are effectively implemented and recorded.

负责执行生产现场的检查，包括现场5s管理，操作流程符合性、数据完整性和GMP规范的符合性，良好的文件记录规范等。与区域管理积极沟通，督促持续改进。

Responsible for the production site inspection, including 5s management, operation process compliance, data integrity and GMP compliance, good documentation, etc. Communicate with area management and push continuous improvement.

支持客户审计及法规审计。

Support clients audit and regulatory inspection.

负责QA相关程序文件的起草，更新和审核。审核生产相关程序文件。保证程序文件的GMP符合性。

Responsible for drafting, updating and reviewing of QA related procedures and examining production related documents, in order to ensure the GMP compliance of procedure documents.

负责提供GMP和质量保证相关的培训。

Responsible for providing training about GMP and quality assurance.

完成主管安排的其他工作和任务。

Complete other tasks assigned by supervisor.

本科及以上

Bechelor degree or above.

化学、药学、制药学，或相关化学专业

Major in chemistry, pharmacy, pharmaceutical or related.

能用英语跟国外客户进行流利的沟通

Can communicate with foreign clients fluently in English.

熟悉MSOffice等办公软件，会使用趋势分析相关工具

Fluent in Microsoft and using trend analysis tools.

需具有至少5年以上制药行业GMP质量保证相关工作经验

At least 1 year GMP quality assurance experience in pharmaceutical industry is required.

具有良好的协调沟通能力

Have good coordination and communication skills.

具有良好的问题调查能力和逻辑判断能力

Have good ability for problem investigation and logical judgment.

能够与团队协同工作，跨部门合作和自我管理

Able to work with team, cross-functional and self-management.

能够跟踪客户质量要求，保证生产进程不受影响，及时放行产品

Able to track customer quality requirements, ensure that the production process is not affected for release products timely.

能够在一定的压力下工作，在规定的时间交付工作

Work under the pressure and deliver work on time.