锦鲤求职

药明合联

QC记录复核专员-大分子检测

锦鲤会替你打开官网网申、按简历自动填表提交,你只需要在关键步骤确认。

岗位描述

1.专职负责QC产品检测组(大分子团队)实验记录的复核工作Full-time record reviewer for QC product testing group (large molecule).2. 教育程度 Education background:化学,生物化学,微生物学,生物工程等相关专业本科及以上学历Bachelor degree or above with education background in Chemistry, Biochemistry, Microbiology, Molecular Biology, Biological Engineering, or others related field..经验 Experience:至少在生物制药一年以上工作经验(大分子理化分析、药典分析或活性分析优先)At least one years' experience in (bio)pharmaceutical industry (Physicochemical,Compendial or Bioassay analysis on large molecule production preferred )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. 工作职责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

质量安全方向的申请准备

先核对岗位要求与自己的经历,再准备档案、投递和面试。

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