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人才招聘

注冊專員(5人)
 

崗位職責:

1、根據部門工作計劃,負責編寫產品國內、國外注冊文件;

2、根據部門產品注冊計劃,負責起草產品分析方法驗證強制降解、穩定性考察簽發QC實施。對驗證圖譜及記錄審核,并整理歸檔;

3、負責產品注冊文件的年度更新,負責翻譯產品質量標準及其他技術文件;

4、負責處理客戶投訴,負責定期收集公司產品國外質量標準和法規更新信息;

5、負責收集外部信息,與外部相關方溝通。

任職要求:

1、具有醫藥或相關專業本科以上學歷;

2、大學英語四級以上,讀寫精通;

3、有藥品國內或國際注冊相關工作經驗者優先;

4、大學英語六級以上,醫藥相關專業優秀應屆畢業生可考慮。

招聘人數:5人

QC員(5人)
 

工作職責:


1、負責對檢驗儀器、設備、試劑、試液、標準品、對照品、滴定液、培養基的管理和使用;

2、開展各項驗證工作,整理編制驗證報告,負責檢驗儀器的驗證立項、方案起草、組織驗證、整理驗證報告;

3、負責對送檢的產品、樣品的化驗工作;

4、負責對公司的原輔料、包裝材料、半成品(中間體)、成品、工藝用水的質量檢驗,并出具驗證報告。


任職要求:


1、具有醫藥或相關專業??埔陨蠈W歷;

2、熟練操作實驗室檢驗儀器,有藥品檢驗相關工作經驗;

3、做事認真細

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