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更新于 8月1日

新分子項(xiàng)目質(zhì)量管理(英語流利)

1.5-2.5萬
  • 常州新北區(qū)
  • 經(jīng)驗(yàn)不限
  • 碩士
  • 全職
  • 招999人

職位描述

色譜儀氣相色譜儀液相色譜儀高效液相色譜儀光譜儀新藥仿制藥化學(xué)藥
崗位職責(zé):
1.熟悉方法確認(rèn)、轉(zhuǎn)移和驗(yàn)證流程。確保檢測(cè)所使用的方法經(jīng)過確認(rèn)、驗(yàn)證或轉(zhuǎn)移。
Familiar with the processes of method verification, transfer, and validation. Ensure that the methods used for testing are confirmed, validated, or transferred.
2.組織方法驗(yàn)證、轉(zhuǎn)移和測(cè)試過程中發(fā)生的實(shí)驗(yàn)室事件、OOX和偏差調(diào)查。
Organize lab event, OOX, and deviation investigations occurring during method validation, transfer, and testing processes.
3.起草所有與項(xiàng)目管理有關(guān)的變更(包括驗(yàn)證,方法和規(guī)格變化等),跟蹤C(jī)APA及時(shí)執(zhí)行。
Draft change control related to project (including validation, method, and specification changes), and track the timely implementation of CAPA.
4.制定項(xiàng)目計(jì)劃,能夠有條不紊地執(zhí)行多項(xiàng)任務(wù),及時(shí)跟蹤項(xiàng)目進(jìn)展,確保項(xiàng)目有序推進(jìn),按時(shí)交付。
Develop project plans, execute multiple tasks in an organized manner, track project progress timely, ensure project proceeds smoothly, and deliver on time.
5.具備新分子樣品的測(cè)試能力(包括不僅限于:寡核苷酸、多肽的色譜和質(zhì)譜分析)。
Testing capability for new modality (Including but not limited to: LC, GC and MS test for Oligo and Peptide).
6.參與客戶審計(jì)和政府審查,及時(shí)完成發(fā)現(xiàn)項(xiàng)的整改。
Participate in client audits and government inspections, and promptly complete corrective actions for identified findings.
7.具備跨團(tuán)隊(duì)溝通能力,與客戶加強(qiáng)溝通,建立穩(wěn)定良好的關(guān)系。
Experience in Cross-team communication, strengthen communication with clients, and establish stable and positive relationships.
任職要求:
1Master
s degree or higher in pharmacy or chemistry-related fields
2Familiar with pharmaceutical production, testing, and quality management, as well as GMP-related regulations
3 Proficient in English, fluent in speaking, with smooth expression and the ability to communicate independently
4Proficient in computer skills, including excellent PPT creation and presentation abilities

工作地點(diǎn)

江蘇省常州市新北區(qū)玉龍北路589號(hào)

職位發(fā)布者

張女士/招聘

昨日活躍
立即溝通
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