M&S-Quality Project Specialist-Hangzhou

Job Information职位信息

Job title职位名称: Quality Project Specialist 质量项目专员

• Location工作地点： Hangzhou Site 杭州工厂
• % Remote working and % of travel expected 远程办公和出差的概率：None, work in site 无，工厂现场办公
• Job type工作类型: Full time全职
• Site/Unit 区域/事业部：Hangzhou/M&S杭州/制造与供应事业部

About the job工作职责

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, include project related and routine production related activities.

执行工厂的验证和确认工作，包括新项目和日常运营相关的验证活动。

• Drive continuous improvement that have a positive impact on productivity, efficiency, and work quality through lean methods and effective quality improvement methods and tools.

通过精益方法和有效质量改进方法及工具，推动对生产力、效率和工作质量产生积极影响的持续改进计划。

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。

Routine operation validation 日常运营验证：

• Prepare validation protocol, implementation validation and finish validation report.

起草验证方案、实施验证，并完成验证报告。

• Organize with the related department to perform validation activities in his/her area.   

组织协调职责范围内的验证活动。

• Ensure all validation in his/her area complemented within defined time frame

确保所有职责范围内的验证按规定的时间框架完成。

Quality Project 质量项目

• Leading and managing continuous improvement projects using the appropriate methodologies.

使用适当的方法领导和管理持续改进项目。

• Provide lean methods and quality improvement tools for quality improvement projects.

为质量改善项目提供精益方法和质量改进工具。

• 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

Pursue progress, discover extraordinary进无止境，探索菲凡

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

进步，外部可见。更好的药物，更好的效果，更高的科学。但是进步离不开人去创造——来自不同背景、不同地区、担任不同岗位的人。所有人都团结在“创造奇迹的渴望”这一使命下。让我们成为这样的人。

在赛诺菲，不分种族、肤色、血统、宗教、性别、国籍、性取向、年龄、公民身份、婚姻状况、残疾或性别认同，我们为所有人提供平等的机会。

观看我们的 ALL IN 视频，并在 sanofi.com 网站上查看我们有关多元化、公平性、包容性的举措。

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!