职位描述
工作职责:
1. 参与苏州工厂化学实验室的维护，确保合规运行 Take part in maintainance of CHIEF chemical lab, ensure operation in compliance.
- 周期性开始实验室内部GMP合规检查，并制定相应的措施；Perform the internal inspection for GMP compliance in lab periodically, and prepare the action plan.
- 每月及时跟踪文件更新通知并及时安排人员完成审核；Monitor QC documents revision notification and finish the revise in time.
- EHS指定人员管理，并按要求执行；Specified person for EHS management, and execute the procedure as requirements.
2.参与化学实验室的日常测试业务的管理 Take part in managment of all rontine test in chemical lab
- 执行并跟踪测试任务；Perform testing and follow the testing status
- 监控测试数据，识别并评估异常数据Monitor the testing result, identify and evaluate the abnormal data.
- 按照GMP要求指定化学实验室内部管理流程，如对照品、滴定 液、试剂、试液、留样、稳定性、剧毒品等管理 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.
- 定期对化学实验室仪器/设备进行维护保养及再确认 Execute the maintainence and requailifcation for daily instrument in chemical lab
- 采购日常耗材 Order for routine consumables
- 委外测试 Contrac inspection
- 支持偏差/CAPA调查 Support for deviation/ CAPA investigation
3. 根据公司计划开展相关的新产品业务 Implement the new product business according to company plan.
- 建立质量标准及测试方法，并相应完成方法学验证 Setup the specification and test procedure, execute the method validaiton accordingly.
- 开展稳定性验证 Excute the stability study
- 委外测试，如相容性研究 Contract testing such as compability study.
- 药检所等官方沟通 Authority communication such as IDC
- 总部沟通 Communication with headquarter
- 资料的准备 CTD dossier preparation CTD
4. 建设团队及培养人员技能 Build team and develop team staff skills
- 组织专项技能培训 Organize detailed skills training
- 起草自我个人发展计划 Prepare individual developing plan
5. 完成主管分配的其它任务 Finish other task assigned by Supervisor
- 供应商审计 Supplier Audit
- 医疗器械业务、山东工厂等跨部门支持 Supporting for MD business and BBraun Shangdong
任职资格:
1.College graduate or above in pharmacy or related major. Well listen, speaking , written and reading English. Good computer skill in Word, Excel, Access
药学或相关专业大专及以上学历，良好的英语听说读写能力, 熟练使用计算机办公软件
2.Bachelor degree with more than 3 years for GMP plant pharma QC lab checmial analysis experience.
本科3年以上GMP工厂药品质量控制实验室化学分析工作经验
3.Good communication and oral delivery in logic and knowledgeable way
良好的口头逻辑沟通能力
4.In plant and travel based on business needs
在工厂及随业务需要的出差
