质量改进工程师
1.3-2万
北京 本科
Product Launch Quality Manager
7-9万·15薪
天津志识恒管理咨询有限公司
北京
不限
本科
10-24
工作地址
远洋国际中心
职位描述
The Job
Lead introduction of new and established products into China, ensuring in depth
knowledge of country requirements to support right first time launches. (Including lead
analytical method transfers to the 3rd Party Labs and commercial product testing
according to local regulatory and company requirements in order to support new product
introductions and the release of commercial batches.)
Accountable for providing the quality standards for product launch within the China
market.
Manage and provide the vision, strategy and leadership oversight on all analytical
responsibilities of company products within China.
Accountable for quality activities for company product launch and commercial testing in
China including sample/reagent management, analytical tech transfer and documentation
support.
Oversee the analytical technology transfer of methods and testing strategies from
company/ CMO donor sites to the 3rd Party contract testing labs in China.
Oversee the analytical testing of commercial products in China, incl. out of specification
results handling and investigations.
Maintain open communications and quick escalation with internal and regional
stakeholders (in Quality, Commercial, Regulatory).
Develop quality work processes to support the relevant analytical activities. These may
include authoring or reviewing templates, guidelines, SOPs, policies or project plans.
Review or author protocols, reports and other documentation related to technology transfer
plans in China.
Work closely within and across functional matrix teams to ensure successful registration
and local market release testing.
Manage contracts, compliance standards and performance review associated with 3rd
Party contract testing laboratories.
Ensure all analytical activities are compliant with the local regulations and company
Quality Management System.
以担保或任何理由索取财物，扣押证照，均涉嫌违法，请提高警惕
为您推荐更多相似职位
