職位描述
1.Maintenance of all SOPs, training files, test methods reports, scan and file all documents for test sample. Scan and store all non-active documents. Maintain and control change within SOP System. Retrieve and control reviews of all active documents within the system for audit and regulatory purposes. Track and maintain revision of timely reviews of all SOPs and other control documents. 2.Assist and lead in the effective and efficient operation of the QA department. Assist in documentation, Regulatory Compliance Training, Internal and external audit to assure regulatory and safety compliance within the industry standard. 3.Responsible for assisting in all QA and regulatory affairs, including but not limited to document control, regulatory compliance training, and internal/external audits. Assist in addressing all lab safety issues and lead in the development /maintenance of quality system. 4.Performs other related duties as assigned by management. Maintain confidentiality in accordance with confidentiality agreement. 崗位要求：1.大學(xué)本科及以上學(xué)歷；2.熟悉掌握有關(guān)藥品管理的法律、法規(guī)和相關(guān)藥品的專業(yè)知識，了解本行業(yè)相關(guān)知識，了解新版GMP等相關(guān)內(nèi)容；有cGMP/cGLP或OSHA Safety相關(guān)經(jīng)驗(yàn)者優(yōu)先；3.有較強(qiáng)的語言表達(dá)能力、組織協(xié)調(diào)和人員管理等能力，做事認(rèn)真細(xì)心謹(jǐn)慎；4.能熟練運(yùn)用英語聽說讀寫，計(jì)算機(jī)軟件應(yīng)用能力強(qiáng)；5.有文件管理經(jīng)驗(yàn)或有文件管理軟件使用經(jīng)驗(yàn)者優(yōu)先。
