工作職責(zé):
1.Perform production work of DP1 or/and DP2.
執(zhí)行制劑一廠或/和制劑二廠的制劑生產(chǎn)工作;
2.Responsible for DS thawing, preparation, vial washing, sterilization, compounding, sterile filtration, filling, freeze-drying and capping.
負(fù)責(zé)原液解凍、生產(chǎn)準(zhǔn)備、洗瓶、滅菌、配制、除菌過濾、灌裝、凍干、軋蓋工序;
3.Responsible for the preparation of disinfectants.
負(fù)責(zé)消毒劑的配制;
4.Responsible for the receiving and distribution of production materials.
負(fù)責(zé)生產(chǎn)材料的領(lǐng)取和發(fā)放;
5.Responsible for the cleaning and disinfection of rooms and equipment in the responsible area.
負(fù)責(zé)責(zé)任區(qū)域的房間和設(shè)備清潔和消毒;
6.Generate and review documents for related manufacturing processes.
起草和審核相關(guān)步驟生產(chǎn)流程文件;
7.Ensure operations strictly adhere to all QA-Controlled documents (such as SOPs, Batch Records) and cGMP/Quality requirements.
確保操作嚴(yán)格遵守所有QA控制文件(例如SOP、批記錄)和cGMP/質(zhì)量要求;
8.Clean and maintain the GMP facility and production equipment, assist to complete preventive maintenance of equipment.
清潔并維護(hù)GMP設(shè)施和生產(chǎn)設(shè)備,配合完成設(shè)備預(yù)防性維護(hù);
9.Responsible for equipment revalidation and APS.
負(fù)責(zé)設(shè)備再驗(yàn)證和APS的執(zhí)行;
10.Responsible for the submission requirements of the production materials for the post.
負(fù)責(zé)本崗生產(chǎn)用物料的提交需求;
11.Responsible for completing various trainings organized by the workshop and the company on time.
負(fù)責(zé)按時(shí)完成車間及公司組織的各項(xiàng)培訓(xùn);
12.Ensure Safety manufacturing.
確保安全生產(chǎn);
13.Ensure that drug product manufacturing conforms to written procedures of Chime biologics.
確保生產(chǎn)過程符合公司的書面流程;
14.Complete other tasks assigned by Immediate superior.
完成上級(jí)領(lǐng)導(dǎo)安排的其他任務(wù)。
任職資格:
1.Graduating students or in school students with college degree or above who major in biological, pharmacy, chemistry or engineering.
生物,藥學(xué),化學(xué)或者工程類大專及以上學(xué)歷應(yīng)屆畢業(yè)生,或者在校學(xué)生;
2.Be familiar with the pharmaceutical industry, and willing to engage to biopharmaceutical industry, good learning ability and good team spirit.
對(duì)制藥行業(yè)有一定認(rèn)識(shí),并且愿意從事生物醫(yī)藥行業(yè),學(xué)習(xí)能力強(qiáng)和好的團(tuán)隊(duì)意識(shí);
3.Be familiar with the production equipment and process of small volume injections and freeze-dried preparations.
熟悉小容量注射劑和凍干制劑生產(chǎn)設(shè)備和工藝;
4.At least 1 years of non-final sterilization injection production or quality management experience.
至少1年以上非最終滅菌注射劑生產(chǎn)或質(zhì)量工作經(jīng)驗(yàn);
5.Be aware of certain aseptic operation, drug production knowledge and excellent academic record in school.
有一定的無菌操作知識(shí)及藥品生產(chǎn)知識(shí),在校學(xué)習(xí)成績優(yōu)秀;
6.Capable of writing detailed reports and summaries and exhibit detail oriented documentation skills.
能夠編寫詳細(xì)的報(bào)告和總結(jié),掌握良好的文檔處理技術(shù);
7.Communicate effectively and work professionally in a team environment.
能夠在團(tuán)隊(duì)中進(jìn)行有效溝通和專業(yè)工作;
8.Skilled in the use of computers and automation-drive equipment.
熟練使用計(jì)算機(jī)和自動(dòng)化驅(qū)動(dòng)設(shè)備;
9.Must be flexible to work on any shift (day, night, weekend) and able to work prolong duration on your feet.
必須適應(yīng)靈活的工作班次(白班、夜班、周末),接受加班;
10.Good oral and written communication skills in English and Mandarin (Read, Write, Verbal).
良好的中英文口頭和書面交流能力(閱讀、寫作、口語)。