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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