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Senior QA Specialist

Location: Guangzhou, China
Position Type: Fixed-Term

岗位设立的目的及目标 / PRIMARY PURPOSE AND OVERALL OBJECTIVE OF THE JOB

This position is responsible for site quality assurance program implementation, including in-coming control, shipping temperature verification, inspection tour in warehouse, sampling check, etc. 
负责执行质量保证程序,包括:进货检验,现场巡检,运输温度确认,样品确认;SAP系统进出库相关操作,供应商沟通等。

 

主要职责 / MAIN ACCOUNTABILITIES

In-coming and outbound control / 进出货检验
a) Perform in-coming inspection, Verify the documentation from supplier along with shipment to make sure meet China MD regulation requirement / 进行进货检验, 确认产品随货同行单,确认对中国医疗器械法规的符合性;
b) Verify temperature when goods arrival, exchange with global on goods release or not / 确认产品到货温度,与总部沟通确认产品是否放行;
c) Evaluate damaged goods and make suggestion on usage decision / 评估受损产品,对产品处置给出建议;
d) Obtain Acceptance Certificate and given to 3PL supplier / 获取产品合格性证明,并交给第三方物流;
d) Inbound and outbound orders confirmation in time and finish all required movement at system, physical and documents level / 及时完成进出库订单确认及根据质量状态安排系统、实物移库及单据的相关操作。

Printing Material Activities Inspection / 贴签活动检查 
a) Onsite inspection on  labeling activities implementation at operation level /检查供应商贴标行为是否按照要求进行;
b) Support 3PL to obtain missing info from internal cross department / 协助第三方物流从内部获取缺失的相关信息;
c) Verify printing material from external supplier or 3PL to make sure meet BMX requirement and China MD requirement  / 确认自制或外购的印刷物料,确保相关法规的符合性;

Warehouse tour / 现场巡检
a)Follow regulation involvement and timely deliver related trainings to the warehouse operators  / 根据法规发展,及时给仓库员工进行培训;
b)Regular implement roving in warehouse to verify goods status and compliance level to regulation / 定期对仓库进行巡检,确保产品储存符合法规要求和梅里埃要求;
c)Timely deliver info. between BMX and 3PL / 及时协调传递梅里埃和第三方物流公司的相关需求;
d)Coordinate the internal and external communication to ensure logistics operation smooth / 协调内部外的沟通确认仓库内相关运用的顺畅

Support Quality team for on-site inspection / 支持相关现场检查或审核;
Support team member on QMS related activities / 支持质量部其他成员相关工作。

 

知识、语言和经验要求 / KNOWLEDGE, LANGUAGE AND EXPERIENCE

1. Education background: biological Engineering, Pharmaceutical related are preferred / 教育背景:生物工程,药学,检验学等相关专业优先
2. 1/2 years working experience as plus / 1-2年工作经验者优先
3. Good command of English in both written and oral / 英文熟练 
4. Good communication and interpersonal skills / 良好的沟通技能
5. Team work and take initiatives; self-discipline and work independently / 团队合作精神、主动工作、具有较强自律能力并能独立工作
6. Work under pressure / 抗压能力强

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