職位描述
工作職責(zé):
1. 日常測(cè)試Routine test
-對(duì)原輔料，包裝材料，中控樣品，成品和穩(wěn)定性研究樣品等進(jìn)行化學(xué)測(cè)試并按GMP要求及時(shí)完成相關(guān)檢驗(yàn)記錄. Perform chemical tests for raw materials, packaging materials, in-process samples, finished products and stability samples; finish testing record and logbook on time per GMP requirement.
- 潔凈介質(zhì)（純化水、注射用水、純蒸汽、氮?dú)獾龋┑臋z測(cè) Tests for purified water, WFI, pure steam, nitrogen, etc.
- 工藝驗(yàn)證、清潔驗(yàn)證、投訴樣品、偏差調(diào)查等的測(cè)試 Tests for process scale-up, cleaning validation, invetigation, etc.
- 供應(yīng)商開(kāi)發(fā)等小樣測(cè)試 Assigned other tasks, such as new vendor development
2. GMP/EHS 合規(guī) GMP & EHS Compliance
- 實(shí)驗(yàn)室文件系統(tǒng)和數(shù)據(jù)庫(kù)的維護(hù) Maintain documetation system and data base;
- 根據(jù)中國(guó)藥典/歐洲藥典和貝朗總部的要求起草相關(guān)SOP和 質(zhì)量標(biāo)準(zhǔn) Generate SOP, Speciffications per ChP, Ph. Eur. and B
Braun Global
s requirement
- 實(shí)驗(yàn)相關(guān)的配制記錄、儀器使用記錄的及時(shí)填寫(xiě) Ensure logbook and record are finished in a timely manner;
- 遵守公司EHS 要求進(jìn)行實(shí)驗(yàn)操作 Follow the EHS requirement;
- 日常5S管理 Lab 5S managment
3. 日常輔助工作 Lab routine management support
- 實(shí)驗(yàn)室試劑、耗材的使用與管理 Routine management of reagents, consumbles;
- 對(duì)照品使用、滴定液標(biāo)定、留樣、穩(wěn)定性實(shí)驗(yàn)等實(shí)驗(yàn)室日常管理 Routine management of reference standards, volumetric solution, retention samples, stability samples, etc.
- 實(shí)驗(yàn)室儀器設(shè)備的日常維護(hù)保養(yǎng)與確認(rèn) Maintainenance, qualification of lab instruments;
- 待檢樣品的接收與確認(rèn) Reception and managment of incoming samples
4. 完成主管分配的其它任務(wù) Other tasks assigned by direct supervisor
- 團(tuán)隊(duì)內(nèi)部技術(shù)分享 Internal sharing;
- 帶教新員工培訓(xùn) Provide on job training for new employee;
- 跨事業(yè)部測(cè)試服務(wù) Provide testing support during cross functional cooperation
任職資格:
College degree or above. Major on pharmaceutical or related.
大專(zhuān)及以上學(xué)歷，藥學(xué)或相關(guān)專(zhuān)業(yè)。
Have basic knowledge of chemical analysis,familiar with ChP, GMP, ICH.
具有化學(xué)分析的基礎(chǔ)知識(shí)，熟悉ChP/GMP/ICH。
ability to read English and good computer skill.
良好的英語(yǔ)讀寫(xiě)能力和電腦操作能力。
More than 1 years of related experience in the pharmaceutical industry .
1年以上醫(yī)藥行業(yè)相關(guān)工作經(jīng)驗(yàn)。
Good communication and oral delivery in logic and knowledgeable way
良好的口頭邏輯溝通能力
In plant and travel based on business needs
在工廠(chǎng)能隨業(yè)務(wù)需要出差
