Associate, Rocephin, Production 專員,羅氏芬,生產(chǎn)
Organize the production in Rocephin area, including the stages of preparation, filling, and visual inspection, cleaning and sterilizing equipments and environment according to SOPs to ensure the all productions are high quality on the basis of GMP.
Support supervisor to organize and manage the team of sterile production , integrate all kinds of resources necessary to ensure the smooth process in sterile production. To make sure that the process is run under fully GMP and Safety control.
在羅氏芬車間組織生產(chǎn)。負(fù)責(zé)羅氏芬整個生產(chǎn)工序,包括準(zhǔn)備,灌裝,目檢階段,根據(jù)SOP對設(shè)備和環(huán)境進(jìn)行清潔和消毒。確保在GMP的基礎(chǔ)上生產(chǎn)出高質(zhì)量的產(chǎn)品。
幫助主管對區(qū)域人員進(jìn)行管理,整合資源保證生產(chǎn)順利進(jìn)行,同時確保整個流程是安全的同時是符合GMP的。
Primary responsibility
1.Organize and manage the production in his or her responsible area
對負(fù)責(zé)區(qū)域人員的組織和管理
By assisting the his or her supervisor to consider capacity of facility and equipment , labor force and production cost make weekly plan for sterile production area to meet requirement of sales
協(xié)助上級對設(shè)備產(chǎn)能,勞動力及生產(chǎn)成本進(jìn)行評估,確保銷售需求。
Monitor line performance; achieve daily/weekly production targets
生產(chǎn)線監(jiān)督,保質(zhì)保量完成每日/每周生產(chǎn)目標(biāo)。
2.GMP and safety surveillance
GMP 和安全監(jiān)督
Through assisting his or her superior, lead team to implement cGMP standard in the production with supervision in order to guarantee the quality of products and performance in international standards. To ensure safe operation protection in daily work based on national or company’s policy.
協(xié)助上級帶領(lǐng)并監(jiān)督區(qū)域人員在生產(chǎn)時實施GMP標(biāo)準(zhǔn),以保證產(chǎn)品質(zhì)量和人員操作符合國際標(biāo)準(zhǔn),根據(jù)國家或公司的政策確保日常的安全操作保護(hù)措施。
Involve in the investigation of the defects during the manufacturing, follow up the implementation of action plan
參與調(diào)查生產(chǎn)過程中的偏差,跟進(jìn)行動計劃的執(zhí)行
3.Document
文件
Check and review the documentation on site such as batch document, logbook are filled in accordance with regulatory requirements timely.
及時檢查并確保現(xiàn)場文件如批記錄、日志的填寫符合規(guī)范。
Support his or her superior to build a professional team
協(xié)助上級建立一個專業(yè)隊伍
By cooperating with his or her Superior , develop and train his or her subordinate to enhance GMP awareness , professional skill and capability . Follow up the team members’ training schedule.
與上級合作,發(fā)展和培訓(xùn)下屬以加強(qiáng)GMP意識,專業(yè)技能和個人能力。跟進(jìn)下屬培訓(xùn)進(jìn)程。
4.Process improvement and organize process Validation
工藝改進(jìn)及工藝驗證
Assistant supervisor optimize the process through parameter perfecting mechanical adjustment of machine and etc, to achieve material localization, increase the quality and have been better output .
Assistant supervisor plan and Implement the process validation to guarantee the quality stability of the changed process.
協(xié)助主管通過調(diào)整運(yùn)行參數(shù)及設(shè)備參數(shù)進(jìn)而優(yōu)化工藝流程,以提高產(chǎn)品質(zhì)量。協(xié)助主管計劃并實施工藝驗證以確保變更工藝后可獲得質(zhì)量穩(wěn)定的產(chǎn)品。
Requirements
Bachelor degree or above.Pharmaceutical technology or relevant fields
本科以上學(xué)歷,藥學(xué)或相關(guān)專業(yè)
At least 1 year related experience in pharmaceutical company
至少1年制藥廠的工作經(jīng)驗
PC skill Knowledge of pharmaceuticals
電腦操作具有制藥方面的知識
Able to take 3 shifts
能夠倒3班
Please send your resume to: mary.meng@roche.com
2011畢業(yè)生可接受,已有一位2011畢業(yè)生被錄用,因班次安排還需增加一人,歡迎加入羅氏!
上海羅氏制藥有限公司是全球十大制藥企業(yè)之一的瑞士羅氏集團(tuán)在中國建立的第一家合資企業(yè),提供腫瘤學(xué)、病毒學(xué)、移植學(xué)等各類關(guān)鍵治療領(lǐng)域的各種處方藥,努力從根本上改善人們的生活質(zhì)量。上海羅氏所有生產(chǎn)線都通過GMP認(rèn)證,2005 年10 月致敏生產(chǎn)基地在張江廠區(qū)落成。