Documentation Specialist 文控专员 (职位编号:00413021)
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:2016-10-10
- 工作地点:苏州-工业园区
- 招聘人数:1人
- 工作经验:3-4年经验
- 学历要求:专业培训
- 职位类别:文档工程师
职位描述
Job Summary:
The job holder will be tasked with the execution of the Documentation Transfer from other Roche sites to RDSZ. Throughout the Project phase, they are also expected to be a support contributor within the SAP roll-out team, master data creation/maintenance and user testing.
Education& Qualifications:
Bachelor’s Degree in Biological Sciences, Business Administration, Chemical Engineering (preferred MedTech) or related field, or equivalent combination of education
and work experience.
Experience:
3-5 years’ experience in a highly regulated cGMP manufacturing environment
At least 2-3 years’ experience in SAP
Good communication and team work.
Good documentation management.
Good understanding of Business Processes
Language skills
Native or fluent Chinese
Fluent English
Main Tasks &Responsibilities主要工作职责:
Transfer existing DOM (Diagnostics OperationsMannheim) Documentation requirements to fit Asia Manufacturing needs and creation of bi-lingual documents and templates.
Responsible for the coordination, involvement and documentation according to timetable.
Review the documents and identify gaps in qualification of the Documentation team.
Responsible for the creation, update, optimize, distribution and maitenance of documentation to fit the Asia Manufacturing and ISO needs.
Assures compliance with Roche corporate requirements regarding Documentation and Records Control requirements for the quality and operations functions.
SAP(UniteD) roll-out member for Manufacturing Module.
Responsible for the organization, maintenance and development of the training processes within the department.
Responsible for Batch Record review and management.
职能类别: 文档工程师
关键字: 文控 DCC 文件管理 13485
公司介绍
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