崗位職責 1. Participate in the establishment, operation and improvement of GMP systems of the company. 參與公司 GMP 質量體系的建立、運行及完善 2. Responsible for obtaining all kinds of drug management and related laws, regulations and technical requirements, and archive management and notification management 負責獲得各類藥品管理及相關法律、法規和技術要求，并作歸檔管理和通報管理 3. Participate in complain, self-inspection of quality management system to ensure its effective operation 參與質量管理體系自檢、投訴等，確保其有效運行 4. Preparation, review, revision and management of GMP documents of the department including SOPs, Protocols, reports, investigation, Etc 參與本部門 GMP 文件的編制、審核、修訂和管理工作 5. Responsible for reviewing SOP prepared by each department 負責審核各部門起草的 SOP 6. Responsible for perform investigations, ****uations and management of quality notifications such as deviation, CAPA, Market compliments, FAR, OOS/OOT change controls etc 負責事件調查及評估，偏差， CAPA ，市場投訴， FRA,OOS/OOT 等等相關質量的管理 7. Participate in preparing, reviewing and revising Specification, Standard Test Procedures and General Test Procedures 參與質量標準、標準檢驗規程、通用檢驗規程的起草、審核和修訂 8. Participate in validation and qualification related work, such as preparing protocol and reports, implementation and monitoring of plans, etc. 參與驗證與確認相關工作，比如方案和報告的起草、方案的實施和跟蹤等 9. Responsible for Supplier/Vendor qualification. Supplier site audits where required. 負責供應商資質確認 10. Responsible for retention samples management, including daily management of retention samples room 負責留樣管理，包括留樣間的日常管理 11. Responsible for the check of laboratory test data 負責實驗室檢測數據的審核 任職要求 1. Bachelor degree or above, major in pharmacy or related 本科及以上學歷，藥學或相關專業 2. Good command on English in listening, speaking, reading and writing, English can be used as working language 英語聽、說、讀、寫能力強，英語可以作為工作語言 3. At least 8 years working experience in pharmaceutical industry; at least 5 years QA team management experience, GMP certification, familiar with GMP related specifications; familiar with FDA certification management skills is preferred 8年以上制藥行業相關工作經驗 ; 5 年以上 QA 團隊管理經驗，參加過 GMP 認證，熟悉 GMP 相關規范；熟悉 FDA 認證相關管理技能者優先 4. Have a strong sense of responsibility and team spirit, good interpersonal communication, coordination and communication skills 有較強的責任心和團隊精神、良好的人際溝通、協調和交往能力