无锡药明合联生物技术有限公司
QC记录复核专员-大分子检测
岗位职责
Job responsibility：1- 按照流程执行记录复核工作，跟进记录复核整个工作流Perform record reviewing following the procedure and follow up the overall workflow2- 收集和总结记录生命流要点，提高整体记录流转效率Collect and summarize all the keys for record workflow to improve the overall turn-around time3- 完成主管分配的任务perform task assigned by supervisor
任职要求
)3. 了解FDA/EMA/CFDA GMP法规Knowledge In FDA/EMA/CFDA GMP regulation熟悉FDA/中国/欧盟法规及ICH等的要求Familiar with FDA/China/EU and ICH GMP requirements熟悉无菌药品生产，熟悉质量体系Familiar with sterile pharmaceutical production and quality system熟悉ADC生产尤佳Perfect for knowing ADC manufacturing well4. 良好的沟通协作能力Good communication and coordination skills良好的计算机办公技能Good computer skills良好的英文听说读写能力尤佳Perfect for good English listening, speaking, reading and writing skills5.
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