職位描述
工作職責:
1. 參與蘇州工廠化學實驗室的維護，確保合規運行 Take part in maintainance of CHIEF chemical lab, ensure operation in compliance.
- 周期性開始實驗室內部GMP合規檢查，并制定相應的措施；Perform the internal inspection for GMP compliance in lab periodically, and prepare the action plan.
- 每月及時跟蹤文件更新通知并及時安排人員完成審核；Monitor QC documents revision notification and finish the revise in time.
- EHS指定人員管理，并按要求執行；Specified person for EHS management, and execute the procedure as requirements.
2.參與化學實驗室的日常測試業務的管理 Take part in managment of all rontine test in chemical lab
- 執行并跟蹤測試任務；Perform testing and follow the testing status
- 監控測試數據，識別并評估異常數據Monitor the testing result, identify and evaluate the abnormal data.
- 按照GMP要求指定化學實驗室內部管理流程，如對照品、滴定 液、試劑、試液、留樣、穩定性、劇毒品等管理 According to GMP requirment to prepare the intermal management process in chemical lab, such as reference, volumentric solution, reagent, prepared solutions, retained samples, stability, high toxic reagent management, etc.
- 定期對化學實驗室儀器/設備進行維護保養及再確認 Execute the maintainence and requailifcation for daily instrument in chemical lab
- 采購日常耗材 Order for routine consumables
- 委外測試 Contrac inspection
- 支持偏差/CAPA調查 Support for deviation/ CAPA investigation
3. 根據公司計劃開展相關的新產品業務 Implement the new product business according to company plan.
- 建立質量標準及測試方法，并相應完成方法學驗證 Setup the specification and test procedure, execute the method validaiton accordingly.
- 開展穩定性驗證 Excute the stability study
- 委外測試，如相容性研究 Contract testing such as compability study.
- 藥檢所等官方溝通 Authority communication such as IDC
- 總部溝通 Communication with headquarter
- 資料的準備 CTD dossier preparation CTD
4. 建設團隊及培養人員技能 Build team and develop team staff skills
- 組織專項技能培訓 Organize detailed skills training
- 起草自我個人發展計劃 Prepare individual developing plan
5. 完成主管分配的其它任務 Finish other task assigned by Supervisor
- 供應商審計 Supplier Audit
- 醫療器械業務、山東工廠等跨部門支持 Supporting for MD business and BBraun Shangdong
任職資格:
1.College graduate or above in pharmacy or related major. Well listen, speaking , written and reading English. Good computer skill in Word, Excel, Access
藥學或相關專業大專及以上學歷，良好的英語聽說讀寫能力, 熟練使用計算機辦公軟件
2.Bachelor degree with more than 3 years for GMP plant pharma QC lab checmial analysis experience.
本科3年以上GMP工廠藥品質量控制實驗室化學分析工作經驗
3.Good communication and oral delivery in logic and knowledgeable way
良好的口頭邏輯溝通能力
4.In plant and travel based on business needs
在工廠及隨業務需要的出差
