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