The Estee Lauder Companies CN.质量控制.QA Manufacturing.QA Third Party.高级亚太运作质量总监 in 上海, China
CN.质量控制.QA Manufacturing.QA Third Party.高级亚太运作质量总监
50%: Provide expertise and leadership on the activities and quality systems necessary to ensure that R&D is operating in full compliance with sound scientific practice, current Good Manufacturing Practices, as applicable, and standard operating procedures. Establish and/or mature a risk based quality management system for R&D. Provide guidance and support to R&D colleagues with respect to change management, deviation reporting, Phase II investigations and other compliance activities. Review and approve/reject data and documentation for GMP activities including, but not limited to, SOPs, batch documentation, IQ/OQ/PQ documents, protocols and reports, specifications, test reports etc. Provide quality oversight to R&D work at third parties, as applicable. Escalates quality issues to the head of R&D Quality in a timely manner. Must have strong problem solving and decision making skills.
40%: Influence R&D stakeholders to embrace the R&D quality strategy. Represent R&D Quality on project teams and quality initiatives. Provide input into development strategies to support innovation, achieve business objectives and maintain GxP compliance. Reviews and approves R&D documentation related to the launch of new products and line extensions.
10%: Perform internal and external quality audits and facilitate corrective actions. Represent R&D Quality in internal audits and/or regulatory inspections. Ensures responses to audit observations/inspection findings (internal and external) are completed in a satisfactory and timely manner.
Minimum Education level:Minimum Years of Experience:% Travel Time:
BS or BA in Chemistry or related degree 8 Years Quality experience 10%
Required Language Proficiency:Licenses or Certifications:
Additional Job Specifications (e.g., physical demands, working conditions, equipment/machinery, specific skills, etc.):
Must have knowledge of cosmetic and OTC drug product regulations. Requires excellent influencing, collaboration and communication skills to direct R&D personnel and discuss quality related issues with management. The candidate must be able to work independently. Ability to work on multiple projects and flexibility to adapt to changing priorities is a must. Must possess strong organizational and planning skills. Expertise from R&D, manufacturing or process development experience is required. Experience in a GMP regulated environment preferred.
出差 接受，5 % 的时间
工作 Quality Assurance
主要地点 Asia Pacific-CN-上海
品牌 Estée Lauder Companies
Job Number: 193808