QA-Temp岗位

Our Team我们的团队：
Manufacturing & Supply consists of 3 manufacturing platforms based on global business units, as well as supporting functions of Quality, Market Supply and Strategy. We are committed to making best class medicines with excellent strategies and tools and delivering them to our patients.
制造与供应事业部包含以3个全球事业部为基础的制造平台，以及质量、供应商、精益战略等支持部门。致力于用优异的战略和工具制造优质的药品并传递到患者手中。
Main responsibilities职责描述：
Please indicate here the main job responsibilities请列举该职位的主要工作职责。
General Mission职责概述
• Implementation validation and qualification related to project.
执行工厂的项目验证和确认工作。
• Training management .
培训管理。
Activities具体职责
• Project related validation and qualification 项目相关验证和确认：
- Prepare and maintenance validation master plan, organize and coordinate for implementation of validation activities.
起草和维护验证主计划，组织和协调相关的验证活动的实施。
- Review for validation protocol and report, review validation deviation.
审核验证方案和报告，审核验证偏差。
- Supervision for implementation of project related qualification and validation
监督项目相关确认和验证的实施。
- Ensuring the proper documentation, review, and approval of qualification and validation deliverables, such as risk assessments, traceability matrices, test scripts, deviations, and summary reports
确保对确认和验证可交付成果进行适当的文档记录、审查和批准，例如风险评估、可追溯性矩阵、测试脚本、偏差和总结报告
- Involve for evaluation for validation requirements, as well as URS preparation.
参与项目相关验证评估，参与URS制定。
• Training management 培训管理：
- Organize with the related department to finish the training activities in his/her area. And archive all training record to ensure GMP compliance.
组织和协调各部门完成所有培训活动、包材所有培训记录，以确保记录GMP符合性。
- As the administrator of the training management system software, complete all operations of the training management system on time
- 作为培训管理系统软件的管理员，按时完成培训管理系统的所有操作。
• Be responsible for HSE in his/her position and job.
对本岗位的职业健康安全环境工作负责。
About you 任职资格:
List here ideally the must-haves criteria to be successful on the role.
请列出胜任该职位所必须具备的条件。
• Experience:
工作经验:
• At least 3 years of experience in qualification & validation roles, with a strong understanding of pharmaceutical manufacturing processes and regulatory requirements.
至少3年确认和验证的工作经验，对药品生产流程和监管要求有很强的理解。
• Skill:
技能：
• Knowledge in qualification and validation, prefer for computerized system validation.
拥有确认和验证知识，特别是计算机化验证相关知识。
• Proficiency in managing multiple projects simultaneously, including planning, execution, and monitoring of quality improvement initiatives.
能够同时管理多个项目，包括规划、执行和监控质量改进举措。
• Proficiency in the use of IT/software tools
熟练使用IT/软件工具
• Ability to analyze complex data, identify trends, and make data-driven decisions to improve quality processes.
能够分析复杂数据，识别趋势，并做出数据驱动的决策，以提高质量流程。
• Leadership abilities to guide and motivate cross-functional teams, manage projects, and drive quality initiatives.
领导和激励跨职能团队、管理项目和推动质量举措的领导能力。
• In-depth understanding of regulatory requirements and Good Manufacturing Practices (GMP) specific to the pharmaceutical industry.
深度了解制药行业的监管要求和良好生产规范（GMP）。
• Technical skill: Pharmacy or related field
专业技能：药学或相关领域
• Education: University
教育背景: (本科)
• Languages: English speaking, reading and writing
语言要求:能使用英语口语、阅读和书写
• Play to Win Behaviors: Stretch; Take Action; Act for Patients & Customers; Think One Sanofi
全力致胜行为: 超越自我, 主动出击, 以患者和客户为本, 团结一致