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深圳翰宇药业股份有限公司

研发QA综合管理员

深圳翰宇药业股份有限公司
523
35
12
Location深圳·龙华区, CN China
SalaryCNY 6,000 - CNY 8,000 /month
Experience1 year – 3 years
Work TypeOnsite
EmploymentNot specified
Working daysMon - Fri
LevelNot specified

Job Description

1、样品管理。 a.负责公司国内、国际报批品种稳定性样品管理工作,根据稳定性方案制定放样取样计划,制定月度考察计划,对检测样品进行分发管理; b.负责受托检验样品接收分发管理; c.负责重要研究批次样品管理(如:新药非临床样品); 2、文件管理。 a.负责GMP模块文件管理(原始记录及相关配套记录发放、归档); b.负责文件升版后申请、发放回收管理; 3、温控设备管理。 a.负责起草库房,恒温恒湿箱,冰箱的温度分布验证方案、执行验证并起草验证报告; b.德图系统维护、报警信息处理,发生温控设备报警时进行跟进,并按流程进行偏差处理; 4、CDMA电子钟管理。 a.每月/每年对CDMA电子钟进行确认管理;

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深圳翰宇药业股份有限公司

深圳翰宇药业股份有限公司

Chinese peptide pharmaceutical company established in April 2003 in Shenzhen, Guangdong with about 883 million yuan of registered capital, listed on the Shenzhen Stock Exchange ChiNext board in April 2011 under code 300199 and recognised as a national high-tech enterprise. Integrates research, manufacturing and sales of peptide medicines and also makes medical devices, with products spanning peptide formulations, peptide active ingredients, custom peptides, cosmetic peptides, solid oral dosage forms, medical devices, peptide skincare and consumer health lines, and it has added chemical products such as vildagliptin tablets and sitagliptin and metformin tablets to its approvals. Operates through branches and subsidiaries including its Pingshan branch and companies in Wuhan, Hong Kong, Gansu Chengji and Dali.

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Job Category

Clinical ResearchClinical Research / CRO

Additional Information