QA专员（放行方向）

Job Responsibilities岗位职责：
1. Participate in the cell bank and product (DS and DP) release activity， including information tracking, document sorting and review. Ensure the product release is completed within the specified timeline.
参与细胞库和产品(原液和制剂)放行工作，包括信息追踪，文件整理和审核。确保按照管理流程要求并在规定时限内完成细胞库和产品放行。
2. Participate in the compliance review of GMP documents and records related to cell bank management and product release. Responsible for the establishment, implementation, and maintenance of release procedure of cell bank and product.
参与细胞库管理和产品放行相关GMP文件和记录的合规性审核。负责细胞库放行和产品放行流程的建立，实施和维护。
3. Participate in the GMP cell bank management activities, including receiving, storage, release, establishment, issuance, shipment, etc.
参与GMP细胞库的管理工作，包括接收、储存、放行、建库、发放、发运等。
4. Oversee the data integrity compliance of related area.
监督相关区域数据完整性的合规性。
5. Participate in the internal audit (self-inspection), and external audit. Responsible for audit support related to cell bank and product release topics, as well as the drafting and review of audit response.
参与内审（自检）和外审，负责细胞库和产品放行相关话题的审计支持，审计回复的撰写和审核。
6. Complete the other tasks as assigned.
完成分配的其他工作。
Qualification 任职资格
1. Bachelor degree or equivalent and above, major in Chemistry, Biology, Pharmacy is preferred.
本科及以上或同等学历，化学/生物/制药或相关专业优先。
2. At least 3 years of experience in manufacturing or quality department of pharmaceutical field.
3年以上制药行业生产或质量相关经验。
Proficiency in the use of common Microsoft office applications.
熟练使用常用Microsoft office应用软件.
3. Gain a fundamental understanding of GMP and related regulatory guidelines across different regions. Proficient in the product release requirements specified in regulations such as those from the NMPA, EMA, and FDA is preferred.
基本了解各地GMP及相关法规指南。熟悉NMPA,EMA,FDA等法规中的产品放行要求的更优。
4. Good written and oral English skills is preferred.
书面和口语英语优秀者优先。
5. Possess strong organizational, communication, and coordination skills, team spirit.
具备良好的组织、沟通、协调能力和团队协作精神。