QA审核员（QA-Reviewer）（化学分析）

1.Must possess a comman******** cGMP requirements as it applies topharmaceutical analytical data for test samples, demonstrate attentionto ******** an******** an understanding of cGMP's relating todocumentation requirements for the final release of analytical testdata.
2.Check/review sample documentation such as sample’s ******** lotnumber, packaging ******** company information an******** the commentsetc. in the Chain of Custody report with the Preliminary report. Makesure the test methods (USP, EP, JP, etc…) request in the Chain ofCustody information match with those in the Preliminary report.
3.Check the report copy: procedure follow, standar******** (USP, EP,etc.) standar******** sample preparat******** concentrat********chemical exp******** instrument cal******** column ******** calculationan******** report. Review technical reports, protocols, final reports,stability reports, an******** forms of documentation as required. Thiswill include the preparation an******** of all data supportingregulatory filings; with the preparat******** rev******** au********an******** of A & D an******** Development documents ******** butnot limite******** protocols, reports, laboratory notebooks, testre******** material spec******** certificates of analysis &compl******** an******** operation procedures; an******** issue progressreports regarding the results an******** of the reviews an******** ofthese documents.
4.Prepare progress reports regarding the status of the data packetreviews an******** findings in these documents an******** releasesupport systems.
5.Performs other relate******** as assigne******** management. Maintainconfidentiality in accordance with confidentiality agreement.
岗位要求：
1.大学本科及以上学历，药学、分析化学及相关专业；
2.具有2年以上制药企业或分析实验室工作经验；
3.熟悉掌握国家有关药品管理的法律、法规、行政规章和所经营药品的专业知识，了解本行业相关知识，了解新版GMP及USP、EP等相关内容；
4.有较强的语言表达能力、组织协调和人员管理等能力，做事认真细心谨慎。