DS QA 原液QA

1. 任职要求Minimum Requirement

• 教育背景/经验

-本科及以上学历，生物学、药学、化学、生物工程等相关专业优先；

-具备GMP环境下质量体系管理经验，熟悉药品研发、技术转移、商业化生产相关质量活动者优先；

• Education background/Experience

- Bachelor degree or above (preferably Biology or Chemistry or Bio-engineering).

- Have relevant knowledge to maintain the robust operation of management system or QA related work experience is preferred;

• 其他要求

-熟悉GMP法规要求，了解NMPA、FDA、EU GMP/PIC/S等国际监管体系；

-具备良好的质量风险识别、问题调查及决策能力；

-良好的英文读写能力；

-具备较强的跨部门协作和沟通影响力。

•

Other requirements

-Familiar with GMP requirements and global regulatory frameworks, including NMPA, FDA, EU GMP and PIC/S;

-Strong capability in quality risk assessment, problem investigation and decision-making;

-Good written and reading skills in English;

-Excellent cross-functional communication,collaboration and stakeholder management skills.

2. 工作职责JOB RESPONSIBILITY

• 负责质量体系与质量监督

-负责原液生产（Drug Substance）、细胞库管理及相关质量体系活动的质量监督；

-作为质量代表参与偏差、变更、CAPA及质量风险管理活动，确保问题得到充分调查、科学评估和有效闭环；

-负责原液批放行审核，确保产品符合注册、法规及质量要求；

-负责确保DS区域数据完整性合规要求

• Quality Systems & Quality Oversight

-Provide quality oversight for Drug Substance (DS) manufacturing, Cell Bank management and related Quality Management System (QMS) activities;

-Serve as Quality Representative in deviation, change control, CAPA and Quality Risk -Management activities, ensuring issues are thoroughly investigated, scientifically assessed and effectively resolved;

-Perform batch release review for Drug Substance products, ensuring compliance with regulatory, quality and registration

requirements;

-Ensure Data Integrity compliance across the DS manufacturing area.

• 参与技术转移与持续验证

-深度参与技术转移（Tech Transfer）、新产品导入（NPI）及商业化项目实施；

-审核工艺验证、持续工艺确认（CPV）及工艺优化相关文件与活动；

-推动产品和工艺生命周期持续改进，支持工艺稳健性提升；

• Technology Transfer & Continued Validation

-Actively participate in technology transfer (Tech Transfer), new product introduction (NPI) and commercial manufacturing

projects;

-Review process validation, continued process verification (CPV) and process optimization activities and related documentation;

-Drive continuous improvement throughout the product and process lifecycle to enhance process robustness and manufacturing

excellence.

• 设备与验证管理

• Equipment, Systems & Validation Management

• 跨部门合作

-与生产、工艺、工程、验证及项目管理团队紧密合作，为业务决策提供质量支持；

-推动质量、合规及运营卓越（Operational Excellence）目标的实现。

• Cross-functional Partnership & Operational Excellence

-Collaborate closely with Manufacturing, Process Sciences, Engineering, Validation and Project Management teams to provide strategic quality support for business operations;

-Drive continuous improvement initiatives to strengthen quality systems, enhance compliance performance and support sustainable business growth.