Senior Chemist--某500强德资医疗公司亚太研发中心

Responsibilities/ Authorities工作职责权限:

1.Confirm to the requirement of regulations and procedure of lab, take charge of physical and chemical test of raw materialsintermediate products and finished products, issue the C.O.A. work out the procurement program of reagent and standard. Take charge of the inspection of retained sample and issuing the certificate.
遵守公司各项管理制度及化验室管理规程;负责进厂的原辅料,包装材料,半成品和最终产品的物理化学检查;负责制定试剂和标准品的采购计划;负责产品的留样考察工作;

2.Chemist should following the instruction of sampling, testing, recording, calculating, to carry out the test according the specification and test method approved, to carry out the stability study for products, and finish his duty in time.
应在工作中必须严格按照有关质量检验标准进行取样、检验、记录、计算或判定等,按照标准操作规程操作,对样品进行检验,对本厂留样产品按规定定期取样进行检查,及时完成检验任务;

3.Responsible to prepare the standard solution and all kinds of reagent solutions, and re-standardizing according to the relative procedure.
负责配制检验用的各类试液、标准溶液及其标化和复标,并定期复标;

4.Responsible for purchasing and managing chemical reference substances against on schedule of R&D.
负责根据研发需要制定对照品、标准物质的定购及其管理。

5.Responsible for the maintenance of instrument and facilities which can be used during daily work.
按相应操作规程自觉维护、保养各种检验仪器、衡器等;

6.Responsible for the hygiene and cleanness of analytical laboratory include equipment, benches, windows, floor etc, and clean glassware when the test finished, wear work clothes during work time.必须保持检验室(包括设备、台面、门窗、地面等)的清洁卫生工作,实验完毕要整理实验台,将使用的仪器复原,玻璃仪器用完后按清洁规程清洗,工作时间按规定着装;

7.Inform the superior immediately when OOS test results occurs. To carry out investigation when needed.
发现不合格的项目和样品及时汇报,协助有关部门进行调查处理;

8.Use the related facilities according the security procedure, improve professional abilities and skills.
按时完成检验任务,按规程使用化验室设施等,学习新的分析方法和新技术,提高工作技能。

9.Creat specification for new drugs and perform analytical method validation for new drug promptly.
制定新药的质量标准并及时完成新药开发过程中质量标准方法验证。

10.Guide and train other staff to improve skill
指导和培训其他的分析人员提高工作技能

Qualifications任职资格:

Education background 教育背景:

The personnel shall possess the education, at least college degree of the pharmaceutical or related sciences, master the related chemical knowledge and R&D experience
必须是药学或相关专业本科以上的学历,掌握相关化学检验知识及新药研发经验

Work experience工作经验:

least two years’ experiences of related job and have the certain theory knowledge and practical operation skills
五年以上相关工作的经验,具有较强的理论知识和实际操作技能,并有一定管理能力;

Competence and skills技能技巧:

Familiar with the article of GMP, can comply with the requirement of GMP in work and carry out the related SOP.
熟悉GMP条款,并能严格的遵守GMP要求和执行相关的SOP

Others其它:

Possess of certain computer operating level and professional English level, can read the professional English reference. 
具有一定的电脑操作水平和专业英语水平,能流利的阅读本专业的外语参考资料。