Propose, lead or participate in continuous improvement initiatives, such as projects to improve quality, cost, delivery and efficiency. Predictively use methodology to improve processes and reduce non-value added waste and activities. (Including process Risk Assessment Summary, use of statistical techniques建议,领导或参与持续改善,例如一些提高质量和效率,降低成本的项目。前瞻性地使用一些方法论提高工艺和降低没有附加值的浪费(包含pRAS和一些数理统计的技术方法)
Financial knowledgeable participate to identify capital spend and budget requirements具备财务知识,识别资本花费和预算需求
Support capacity planning/ management, identify needs of new equipment or processes. Participate or lead the layout design / implementation for facility and equipment, can implement machine qualification and process validation支持产能计划和管理,识别新设备或新工艺需求参与或指导设备设施的布局涉及,能执行设备验证和工艺验证。
In partnership with the Quality department, participate to the development of the quality system and its day to day implementation和质量部合作,参与开发质量体系确保日常执行
Understand the Quality philosophy based on FDA QSRs, ISO 9000 and CFDA requirements理解基于FSA QSRs, ISO9000和中国食品药品监督管理局要求的质量方针
Understand, compile and control non-conformance data and product traceability理解,符合,控制合规以及产品的追溯性
Understand computer software validation requirements理解计算机软件验证需求
Perform all job duties in full accordance with: 履行所有下述职责
The J&J policies on Information, Assets protection, Maintain password(s) confidential, protect强生在信息技术,资产保护,密码的保密性
Critical Business Information.关键业务信息
All J&J policies and local regulations. 所有强生的政策和本地法规
The policies of the Health Care and Environmental programs. 健康护理和环境程序政策
Propose, develop or participate in programs to improve H&S and Environment建议,开发或参与项目以提高环境健康
Full responsibility and ownership (like all employees on site) for all cleaning process related audits (internal, Corporate, External, for Quality, H&S, Environment, etc.) 负责所有清洗工艺相关的审核(内部,公司层面,外部,质量,环境健康相关)