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                Specialist, Quality System
更新日期:2020-06-12
职位描述公司简介
- Support the start-up of Quality Systems for the site.
 - Execute and maintain the Quality Systems at the site.
 - Document Management System
 - Write, Revise, Review and Approve SOPs, protocols, reports or records.
 - Conduct training
 - Provide guidance on cGMP, Good Documentation Practices (GDP) and Data Integrity requirements.
 - Training/Learning Management System (LMS)
 - Maintenance of training curriculum/tasks.
 - Custodian and archival of training records.
 - Provide guidance on LMS usage.
 - Trackwise System (TW)
 - Provide guidance on deviation management, change control and CAPA.
 - Conduct training and provide guidance on TW system usage.
 - Communicate quality systems and compliance requirements effectively to peers and stakeholders.
 - Provide compliance support to staff in all departments.
 - Participate in regulatory, customer and internal audits.
 - Any other tasks as and when assigned by the supervisor/line manager.
 
Key Requirements.
- Familiarity with Regulatory requirements and local Codes & Standards (e. g. , FDA, EMEA, GAMP and ICHQ7)
 - Good knowledge and experience of the practical and theoretical requirement of validation program in GMP facility
 - Good leadership skills
 - Strong interpersonal skills
 - Effective Communicator (oral and written)
 - Exhibit good quality decision making traits
 - Meticulous and Systematic
 - Analytical Mind
 - Ability to define specific goals clearly, to develop and prioritize activities
 - Team player, with strong focus on safety, quality and timelines
 
联系方式:
公司网址:http://www.lonza.com.cn
公司地址:广州市海珠区金辉路39号
联系电话:34973888-2590
龙沙(中国)投资有限公司成立于2003年9月,是瑞士龙沙集团全资在广州设立的投资性公司。公司旨在于医药、化工及生命科学领域进行投资和再投资,同时提供以下服务:
-协助或代理龙沙所投资企业的货物及设备采购业务,并在国内外市场销售他们的产品;
-为龙沙所投资企业提供售后服务、技术支持及人力资源服务;
	
-为投资者提供咨询服务并为龙沙的关联公司提供市场信息、投资政策等咨询服务。
	
龙沙(中国)投资有限公司
- 企业性质: 三资企业
 - 业务范围: ITO,KPO
 - 所属行业:医药/生物工程
 - 公司地址:广州市海珠区金辉路39号
 
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最近浏览的职位
- Specialist, Quality System2020-06-12
 
 