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勃林格殷格翰(中國)投資有限公司——招聘QC研究員

發(fā)布日期：2015-01-27 瀏覽次數(shù)：1071

招聘崗位：QC Scientist (Biopharma) / QC 研究員
Basic Purpose of the Position 崗位的基本目標(biāo) 
1. Perform testing of raw material and biological APIs and Drug Product, deviation investigations and equipment and reagent management under company’s guideline and cGMP regulation. Ensure the accuracy and reliability of test results to assure product quality and support production and registration. 在公司管理規(guī)范和cGMP法規(guī)要求下進(jìn)行物料及產(chǎn)品的分析化驗(yàn)，偏差調(diào)查，設(shè)備及試劑等的管理。確保檢驗(yàn)數(shù)據(jù)準(zhǔn)確可靠，科學(xué)反映產(chǎn)品的質(zhì)量特征，從而支持生產(chǎn)及產(chǎn)品注冊。

 2. To comply and improve each procedure to maintain a high efficiency with reliability under a competitive cost. 嚴(yán)格執(zhí)行并持續(xù)改進(jìn)各項(xiàng)標(biāo)準(zhǔn)要求以具有競爭力的成本保持檢驗(yàn)的高效可靠。 

Accountabilities 職責(zé) 
1. Responsible for arranging and carrying out testing for raw materials, packaging materials, intermediates, bulk products and finished products, testing for pharmaceutical water. Ensure to complete incoming analytical requests accurately and timely 負(fù)責(zé)組織及實(shí)施原輔料、包裝材料、中間品、待包裝品和成品的檢測工作。確保按時(shí)完成樣品檢測。 
2. Participate into establish testing Specifications for product, raw materials and packaging materials, and relevant SOPs/Forms according to given instructions, ensure to comply with GMP, regulatory and BI requirements 參與建立產(chǎn)品,原輔料,包裝材料的質(zhì)量標(biāo)準(zhǔn),以及相關(guān)的SOP/記錄表,以確保符合GMP、規(guī)章和BI的要求 
3. Execute lab equipment qualification and maintenance, ensure to perform all tests smoothly 實(shí)施實(shí)驗(yàn)室設(shè)備的確認(rèn)和維護(hù)保養(yǎng)，以確保順利進(jìn)行所有檢測任務(wù)
4. Participate in analytical method transferring and validation. 參與產(chǎn)品分析方法轉(zhuǎn)移和驗(yàn)證 。 
5. Participate in OOS investigation. 參與調(diào)查處理超標(biāo)結(jié)果。 
6. Maintain the equipment, glassware, reagent etc. in productivity and cost saving status meanwhile complies with requirement from SFDA and company. 維持設(shè)備，玻璃器皿和試劑等管理以確保在符合SFDA 和公司指南的要求下高效，經(jīng)濟(jì)。 
7. Follow related SOPs and regulations strictly in lab. 嚴(yán)格執(zhí)行實(shí)驗(yàn)室的相關(guān)標(biāo)準(zhǔn)作業(yè)程序和規(guī)章制度 
8. Fill in related documentation such as BAR, other logbook etc., timely to ensure the reliability of content as per requirement of SOPs. 及時(shí)按照SOP的要求填寫相關(guān)文件記錄如批檢驗(yàn)記錄、儀器使用和維護(hù)記錄等并保證內(nèi)容的真實(shí)可靠。 
9. Take part in actively in correction to the observations found in self-inspection. 積極參加對自檢中所發(fā)現(xiàn)缺陷的整改 
10. Participate actively in serials training required to be held by internal and external. 積極參加由內(nèi)部或外部組織的系列培訓(xùn)活動(dòng)。 
11. Develop all kinds of skills in relation to work field and pursue continuous improvement 發(fā)展各種工作技能并追求持續(xù)的改進(jìn) Required Experience 所需的工作經(jīng)驗(yàn)背景 At least 3 years’ experience in Quality Control in the biopharmaceutical or pharmaceutical industry. Have experience in raw material test; Familiar with HPLC, GC application in protein or chemical analysis; Multinational pharmaceutical company experience is preferred. 至少有3年以上生物醫(yī)藥或化學(xué)醫(yī)藥行業(yè)工廠QC工作經(jīng)驗(yàn)。具有原輔料檢驗(yàn)經(jīng)驗(yàn)；熟悉HPLC, ELISA等在蛋白質(zhì)或化藥分析中的應(yīng)用；跨國制藥企業(yè)經(jīng)驗(yàn)優(yōu)先考慮。 
Degree / Education 學(xué)位/教育 
Bachelor or above, Bio Chemistry/Pharmaceuticals/Instrument analysis 學(xué)士及以上，生物制藥或儀器分析相關(guān)專業(yè) 
Required Capabilities (Skills, Experience, Competencies) 所需的能力(技能、經(jīng)驗(yàn)、勝任能力) 
1. Good knowledge of GMP 良好的GMP相關(guān)知識(shí) 
2. Familiar with related local regulations 熟悉當(dāng)?shù)叵嚓P(guān)法規(guī)
 3. Good team player 良好的團(tuán)隊(duì)合作 
4. Good organizing and communication ability 良好的組織溝通能力 
5. Sense of urgency, precision and reliability 緊迫感，不斷進(jìn)取，可信 
6. Willing to learn and open to new ideas, constructive thinking, initiative and proactive 坦誠，積極進(jìn)取 
7. Be able to work under pressure 能承受壓力 
8. Can create new idea or innovative method to mutilple functions 能對多項(xiàng)職能進(jìn)行創(chuàng)新 
9. Good coaching ability 良好的指導(dǎo)能力 
10. Good time management skill良好的時(shí)間管理能力



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