職位描述
GMP認(rèn)證微生物工程限度檢驗(yàn)無(wú)菌檢驗(yàn)
Main responsibilities職責(zé)描述:
1. To carry out Sampling, Analytical testing and Reporting of API, raw materials, active ingredients, packaging materials, in process samples, intermediates, finished products and, as well as the monitoring of utility and environment according to the test methods GMP requirements.
按照分析方法和GMP的要求進(jìn)行原輔料、包材、中控樣品,以及成品的取樣,檢驗(yàn)及報(bào)告。執(zhí)行公用工程介質(zhì)和環(huán)境監(jiān)控;
2. To Ensure that analyses are carried out on time and are in compliance with the specifications. Participate to the OOS investigations and the quality assessment.
確保樣品及時(shí)檢驗(yàn)并符合質(zhì)量標(biāo)準(zhǔn)的要求。參與超標(biāo)結(jié)果的調(diào)查以及產(chǎn)品質(zhì)量評(píng)估;
3. Perform analytical transferring / validation for the new products.
分析方法轉(zhuǎn)移及驗(yàn)證;
4. To assist writing draft sops, draft qualification protocols of the analytical instruments and the analytical methods. Assist perform the qualification work.
協(xié)助編寫(xiě)標(biāo)準(zhǔn)操作規(guī)程、儀器確認(rèn)方案及分析方法。協(xié)助進(jìn)行驗(yàn)證工作;
5. To be the back up of the other analysts to achive the team target.
其它分析員缺席時(shí),作為替補(bǔ)以完成團(tuán)隊(duì)目標(biāo)。
6. Be engaged in the lab continuousely improvement for technical and management perpurse. Advocate and execute the sms concept and practice.
參與實(shí)驗(yàn)室管理及技術(shù)的持續(xù)改善活動(dòng)。倡導(dǎo)和實(shí)施賽諾菲管理系統(tǒng)。
7. Responsible help the supervisor for lab investigation and trouble shooting.
協(xié)助實(shí)驗(yàn)室主管負(fù)責(zé)實(shí)驗(yàn)室調(diào)查和問(wèn)題的解決。
8. Support new project preformed in the lab.
支持新的項(xiàng)目在實(shí)驗(yàn)室的執(zhí)行。
9. Quality Department HSE Responsibilities質(zhì)量部HSE職責(zé)
- Responsible for following the company’s HSE policy, and integrated all requires into daily job.
負(fù)責(zé)貫徹公司HSE的有關(guān)規(guī)定,把公司HSE制度的措施貫徹到每個(gè)具體環(huán)節(jié)。
- Incorporate HSE work into the work plan
將HSE工作納入工作計(jì)劃中。
- Organize the implementation of HSE management target plan of this department, implement HSE rules and regulations, HSE operation procedures and HSE technical action plan.
組織實(shí)施本部門(mén)HSE管理目標(biāo)計(jì)劃,落實(shí)HSE規(guī)章制度、HSE操作規(guī)程和HSE技術(shù)措施計(jì)劃。
- Regularly carry out to identify HSE potential hazards and develop action plan and finish on time.
定期開(kāi)展本部門(mén)HSE隱患排查治理工作,制定整改計(jì)劃并按時(shí)完成隱患整改。
- Timely working out of employee opinions.
負(fù)責(zé)部門(mén)級(jí)HSE教育與考核工作;及時(shí)處理員工提出的意見(jiàn)。
- Actively cooperate with HSE management to prevent accidents happens.
積極配合HSE管理工作,防止各類事故的發(fā)生。
- Regularly carry out +QDCI meetings at all levels considering HSE8 requirements. Feedback HSE issues in a timely and accurate manner, and actively implement remediation.
定期開(kāi)展本部門(mén)各級(jí)+QDCI會(huì)議,結(jié)合HSE8要求,及時(shí)、正確填寫(xiě)和反饋各類HSE問(wèn)題,并積極落實(shí)整改。
- Participate in the investigation for accidents, analyze the root causes of accidents from the quality management perspective, and related CAPA.
參加事故調(diào)查分析工作,從質(zhì)量管理角度分析事故原因,提出事故防范措施。
- Responsible for design annual department PASS plan, and ensure implementation as planned.
負(fù)責(zé)制定年度部門(mén)PASS計(jì)劃,并按進(jìn)度組織實(shí)施。
10. Sanofi (Beijing) Pharmaceutical Co., Ltd. Energy Policy: "Quality as the top priority, through technical, behavioral, human consciousness, continuously reduce the rate of energy consumption in product value, benefit the users, and promote company development". Good awareness of energy conservation is required, participate in energy saving actions, and assist in the continuous development of the energy management system.
崗位要求:
? Experience:
工作經(jīng)驗(yàn): 至少3年,有LIMS經(jīng)驗(yàn)優(yōu)先
? Soft skill:
通用技能: 掌握Office軟件基本功能
? Technical skill: NA
專業(yè)技能: 微生物檢驗(yàn)相關(guān)技能如限度檢驗(yàn),無(wú)菌檢驗(yàn),菌種傳代保藏鑒定等
? Education:
教育背景:本科或以上, 藥學(xué)、化學(xué)、生物、食品相關(guān)專業(yè)
? Languages:
語(yǔ)言要求: 至少英語(yǔ)四級(jí)或同等級(jí)別,精通專業(yè)英語(yǔ)口語(yǔ)優(yōu)先
? Take The Lead Behaviours:Aim Higher、Act for Patients、Be Bold and Lead Together
更高目標(biāo)、以患者為本、勇于創(chuàng)新、共同領(lǐng)導(dǎo)