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工作職責(zé):
1. 負(fù)責(zé)DMPK蘇州/上海實(shí)驗(yàn)室的化合物和生物樣品的全流程管理，包括但不限于：
86 化合物及樣品的接收、分裝、分發(fā)、儲(chǔ)存及銷毀
86 確保全流程化合物及樣品的安全性、完整性和可追溯性
2. 對接部門上下游功能團(tuán)隊(duì)，設(shè)計(jì)并優(yōu)化化合物及樣品管理流程，提升操作效率與合規(guī)性;
3. 制定并持續(xù)優(yōu)化標(biāo)準(zhǔn)操作規(guī)程（SOP），識(shí)別關(guān)鍵人為操作節(jié)點(diǎn)（如手工分裝、數(shù)據(jù)錄入等），建立防差錯(cuò)機(jī)制，強(qiáng)化質(zhì)量管理體系；
4. 及時(shí)應(yīng)對操作過程中的異常情況，提供合理的解決方案，并推動(dòng)問題閉環(huán)管理；
5. 客戶審計(jì)及來訪接待：負(fù)責(zé)客戶審計(jì)的全程支持，確保審計(jì)質(zhì)量；對外展示專業(yè)能力，提升客戶信任度；根據(jù)審計(jì)反饋優(yōu)化內(nèi)部流程；
6. 高效完成主管交付的其他任務(wù)。
1. Responsible for the end-to-end management of compounds and biological samples across the Suzhou/Shanghai DMPK sites, including but not limited to:
86 Receiving, aliquoting, distributing, storing, and disposing of compounds and samples;
86 Ensuring the safety, integrity, and traceability of compounds and samples throughout the entire process.
2. Collaborate with upstream and downstream functional teams to design and optimize compound and sample management processes, enhancing operational efficiency and compliance.
3. Develop and continuously optimize standard operating procedures (SOPs), identify critical manual operation points (e.g., manual aliquoting, data entry), establish error-proofing mechanisms, and strengthen the quality management system.
4. Promptly address abnormal situations during operations, provide reasonable solutions, and drive closed-loop problem management.
5. Provide full support for client audits to ensure audit quality; demonstrate professional capabilities to enhance client trust; optimize internal processes based on audit feedback.
6. Efficiently complete other tasks assigned by supervisors.
任職資格:
1. 本科及以上學(xué)歷，碩士優(yōu)先；化學(xué)、醫(yī)藥、生物等相關(guān)專業(yè)背景；
2. 3年以上醫(yī)藥行業(yè)實(shí)驗(yàn)室工作經(jīng)驗(yàn)；有團(tuán)隊(duì)管理經(jīng)驗(yàn)者優(yōu)先；
3. 具備良好的中英文讀寫能力，可熟練使用英語溝通的優(yōu)先；
4. 具備快速學(xué)習(xí)能力及優(yōu)秀的溝通協(xié)調(diào)能力，對新技術(shù)、新方法保持開放態(tài)度，能持續(xù)提升專業(yè)能力；
5. 具備敏銳的流程優(yōu)化意識(shí)，善于發(fā)現(xiàn)問題并提出改進(jìn)方案，熟悉GLP/GMP規(guī)范者優(yōu)先。
1. Bachelor’s degree or above, with a Master’s preferred; background in chemistry, pharmaceuticals, biology, or related fields.
2. Over 3 years of laboratory experience in the pharmaceutical industry; team management experience is a plus.
3. Proficient in reading and writing in both Chinese and English; ability to communicate effectively in English is preferred.
4. Quick learner with excellent communication and coordination skills; open to new technologies and methods, and committed to continuous professional development.
5. Keen awareness of process optimization, skilled at identifying issues and proposing improvements; familiarity with GLP/GMP standards is preferred.