Job Responsibilities崗位職責(zé)：
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.
參與細(xì)胞庫和產(chǎn)品(原液和制劑)放行工作，包括信息追蹤，文件整理和審核。確保按照管理流程要求并在規(guī)定時(shí)限內(nèi)完成細(xì)胞庫和產(chǎn)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.
參與細(xì)胞庫管理和產(chǎn)品放行相關(guān)GMP文件和記錄的合規(guī)性審核。負(fù)責(zé)細(xì)胞庫放行和產(chǎn)品放行流程的建立，實(shí)施和維護(hù)。
3. Participate in the GMP cell bank management activities, including receiving, storage, release, establishment, issuance, shipment, etc.
參與GMP細(xì)胞庫的管理工作，包括接收、儲(chǔ)存、放行、建庫、發(fā)放、發(fā)運(yùn)等。
4. Oversee the data integrity compliance of related area.
監(jiān)督相關(guān)區(qū)域數(shù)據(jù)完整性的合規(guī)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.
參與內(nèi)審（自檢）和外審，負(fù)責(zé)細(xì)胞庫和產(chǎn)品放行相關(guān)話題的審計(jì)支持，審計(jì)回復(fù)的撰寫和審核。
6. Complete the other tasks as assigned.
完成分配的其他工作。
Qualification 任職資格
1. Bachelor degree or equivalent and above, major in Chemistry, Biology, Pharmacy is preferred.
本科及以上或同等學(xué)歷，化學(xué)/生物/制藥或相關(guān)專業(yè)優(yōu)先。
2. At least 3 years of experience in manufacturing or quality department of pharmaceutical field.
3年以上制藥行業(yè)生產(chǎn)或質(zhì)量相關(guān)經(jīng)驗(yàn)。
Proficiency in the use of common Microsoft office applications.
熟練使用常用Microsoft office應(yīng)用軟件.
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及相關(guān)法規(guī)指南。熟悉NMPA,EMA,FDA等法規(guī)中的產(chǎn)品放行要求的更優(yōu)。
4. Good written and oral English skills is preferred.
書面和口語英語優(yōu)秀者優(yōu)先。
5. Possess strong organizational, communication, and coordination skills, team spirit.
具備良好的組織、溝通、協(xié)調(diào)能力和團(tuán)隊(duì)協(xié)作精神。