職位描述
1.Must possess a command of cGMP requirements as it applies to pharmaceutical analytical data for test samples, demonstrate attention to detail, and possess an understanding of cGMP's relating to documentation requirements for the final release of analytical test data. 2.Check/review sample documentation such as sample’s description, lot number, packaging information, company information and even the comments etc. in the Chain of Custody report with the Preliminary report. Make sure the test methods (USP, EP, JP, etc…) request in the Chain of Custody information match with those in the Preliminary report. 3.Check the report copy: procedure follow, standard using (USP, EP, etc.) standard and sample preparation, concentration, chemical expiration, instrument calibration, column dimension, calculation and units report. Review technical reports, protocols, final reports, stability reports, and other forms of documentation as required. This will include the preparation and review of all data supporting regulatory filings; with the preparation, review, auditing, and control of A & D and Methods Development documents including, but not limited to protocols, reports, laboratory notebooks, test requests, material specifications, certificates of analysis & compliance, and standard operation procedures; and to issue progress reports regarding the results and status of the reviews and audits of these documents. 4.Prepare progress reports regarding the status of the data packet reviews and quality findings in these documents and data release support systems.5.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，藥學(xué)、分析化學(xué)及相關(guān)專業(yè)； 2.具有2年以上制藥企業(yè)或分析實(shí)驗(yàn)室工作經(jīng)驗(yàn)；3.熟悉掌握國(guó)家有關(guān)藥品管理的法律、法規(guī)、行政規(guī)章和所經(jīng)營(yíng)藥品的專業(yè)知識(shí)，了解本行業(yè)相關(guān)知識(shí)，了解新版GMP及USP、EP等相關(guān)內(nèi)容；4.有較強(qiáng)的語(yǔ)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。
