苏州 [切换城市] 苏州招聘苏州质量管理/安全防护招聘苏州质量管理/测试工程师(QA/QC工程师)招聘

(Sr) Engineer-Method validation

罗氏诊断产品(苏州)有限公司

  • 公司规模:150-500人
  • 公司性质:外资(欧美)
  • 公司行业:制药/生物工程

职位信息

  • 发布日期:2017-06-27
  • 工作地点:苏州-工业园区
  • 招聘人数:1人
  • 工作经验:5-7年经验
  • 语言要求:英语 熟练
  • 职位类别:质量管理/测试工程师(QA/QC工程师)  

职位描述

职位描述:

Job Summary职位概述:
The job holder ensures to meet / perform
-Legal, regulatory and business framework
-Product review
-Deviation management
-Master data creation and maintenance
-Data analysis
-Product issues analysis

Main Tasks & Responsibilities主要工作职责:

-Execution of method validations and equipment qualifications to qualify QC test system
-Responsible for initiation protocol, report of method validation and equipment qualification
-Responsible for processing deviation reports (e.g. out of specification, events, deviations, Capa-Processes)
-Supporting to process product issues and/ or raw material issues within production and quality issues in the market
-Build and maintain master data in SAP system
-Support to evaluate test method and equipment for re-validation
-Ensure alignment with the regulatory specifications, defined guidelines as well as legal specifications of work, health & environmental safety
-Supporting of development and implementation of continuous optimization
-Other task assigned by supervisor

Basic Requirements of the Job基本任职资格:

Education& Qualifications教育背景与专业资格:
Bachelor’s Degree in Pharmaceutical Engineering or Chemistry or Biochemistry Science
Master’s Degree preferred.
Experience工作经验:
-At least 4 years’ experience for bachelor’s degree in the required functional area
-At least 2 years’ experience for master Degree in the required functional area
-Preferred with SAP operation experience
Language skills
Native or fluent Chinese
Fluent English

Professional Competencies/skills专业能力/技能:
-Professional and positive approach
-Diligent with attention to detail
-Ability to cope with ambiguity and pressure
-Collaborates well, while also is capable of dealing with conflict resolution
-Dynamic and vigorous
-Self-motivated & self-sufficient
-Effective communicator at all levels
-Ability to convey concepts to different management levels and across functions within the organization/project
-Team player with the ability to work on their own initiative
-Assertive, adaptable and creative
-High cultural awareness and proven ability to work with a broad range of cultures
-Ability of systematic, interlinked and analytic as well as strategic thinking
-A “can-do” attitude and willingness to go the extra mile when required

职能类别: 质量管理/测试工程师(QA/QC工程师)

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公司介绍

作为体外诊断的全球市场领导者,罗氏诊断致力于为全球实验室和医院提供创新型检测和技术,从而帮助医疗专业人士为患者做出正确的医疗决策。

罗氏诊断苏州是罗氏诊断全球在亚太地区建立的首个生产和研发基地,公司将为罗氏集团在中国及亚太地区取得快速成长奠定坚实的基础。其总投资额达4.5亿瑞士法郎,包括9座大楼,占地面积超过48,000平米。2018年10月29日,罗氏诊断产品(苏州)有限公司在园区正式开业。

我们倡导“以人为本”的管理理念,致力于为员工打造理想的工作场所。真诚、勇气、激情是罗氏的的价值观。

在罗氏,改善患者的生活是我们每天努力工作的初衷,个人价值的实现将会变得更有意义,通过与工作伙伴的共同努力,倾力造福患者。

在罗氏,你将拥有一份富有挑战性的工作,同时也能够在生活和职业之间找到一种健康的平衡。

在罗氏,职业发展将跨越职能和地域,我们坚信每一个你都有自己的潜力。

这不仅是一份工作,更是你新的起点!

罗氏诊断苏州,期待你的加入!

联系方式

  • 公司地址:地址:span钟园路259号