Quality System Intern

M&S China Job Description

中国制造与供应事业部职位说明书

Job Information职位信息

Job title职位名称: QS intern/质量体系实习生

• Grade级别: 实习生
• Location工作地点： Beijing
• % Remote working and % of travel expected 远程办公和出差的概率：≤10%
• Job type工作类型: 实习生
• Site/Unit 区域/事业部：Beijing site  北京工厂
• Solid Line Manager(Job Title and Name) ：

直线汇报上级（职位名称+姓名）： associate manager of quality system and compliance / Bob Bao

• Dotted Line Manager(Job Titel and Name):
• +姓名）：N/A
• Job description valid from:

修订时间：02/2025

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：

Assist QualiPSO CMS management 协助QualiPSO中的CMS管理

System Management:系统管理

• Oversee the local implementation and management of the QualiPSO Clinical Management System (CMS).
• QualiPSO内容管理系统（CMS）在本地的实施和管理。
• Ensure the CMS meets local business needs while aligning with global standards and processes.
• CMS满足本地业务需求，同时与全球标准和流程保持一致。

• Evaluate the impact of system changes or updates on local processes and users.
• Collaborate with the global QualiPSO team to implement new features or updates.
• QualiPSO团队合作，实施新功能或更新。

User Support and Training:用户支持和培训

• Provide guidance and support to local users on QualiPSO CMS operations and best practices.
• QualiPSO CMS操作和最佳实践的指导和支持。
• Coordinate and deliver training sessions for new users and refresher courses for existing users.

Reporting and Analytics:报告和分析

• Generate and analyze reports on CMS usage, document statuses, and other relevant metrics.
• CMS使用情况、文档状态和其他相关指标的报告。
• Provide insights to local management on document management performance and trends.

Compliance and Audit Support:合规性和审计支持

• Ensure QualiPSO CMS processes comply with local and global regulatory requirements.
• QualiPSO CMS流程符合本地和全球法规要求。
• Support internal and external audits related to document management and control.

Continuous Improvement:持续改进

• Stay updated on QualiPSO CMS features and best practices.
• QualiPSO CMS功能和最佳实践的最新动态。
• Propose and implement process improvements and system enhancements.

Issue Resolution:问题解决

• Act as the first point of escalation for local QualiPSO CMS issues.
• QualiPSO CMS问题的第一联络人。
• Collaborate with IT support and the global QualiPSO team to resolve complex problems.
• IT支持和全球QualiPSO团队合作解决复杂问题。

As a quality transformation coordinator 作为质量变革协调员

Project Management 项目管理

• Coordinate and oversee quality transformation projects across different departments and functions

Transformation Management 变革管理

• Practice management efforts related to quality transformation initiatives
• Support managers and employees in adapting to new quality processes and systems

Process Improvement 流程改进

• Identify opportunities for quality process improvements and efficiency gains
• Collaborate with cross-functional teams to streamline quality-related workflows

Digital Transformation 数字化转型

• Support the digitalization of quality management systems and processes
• Coordinate the implementation of new quality-related technologies and tools
• Ensure data integrity and compliance in digital quality management systems

As a QualiPSO BSO & User management administrator作为QualiPSO系统本地系统及权限管理员

Training and Support 培训支持

• Provide first-level support for user queries and issues related to QualiPSO
• QualiPSO相关的一级支持，解答查询和问题
• Ensure proper configuration and use of these modules according to Sanofi's global standards
• 确保按照赛诺菲全球标准正确配置和使用这些模块

Change Management

• Communicate system changes and updates to local users

Continuous Improvement 持续改进

• Stay updated on QualiPSO developments and new features
• QualiPSO的发展和新功能
• Propose and implement improvements to local QualiPSO processes
• QualiPSO流程的改进
• Participate in global QualiPSO user communities to share best practices and learn from other sites
• QualiPSO用户社区，分享最佳实践并向其他站点学习

Quality Department HSE Responsibilities质量部HSE职责

• Incorporate HSE work into the work plan
  • HSE工作纳入工作计划中。
• Actively cooperate with HSE management to prevent accidents happens.
  • HSE管理工作，防止各类事故的发生。
• HSE8 requirements. Feedback HSE issues in a timely and accurate manner, and actively implement remediation.
  • HSE8要求，及时、正确填写和反馈各类HSE问题，并积极落实整改。
• Participate in the investigation for accidents, analyze the root causes of accidents from the quality management perspective, and related CAPA.
• Sanofi (Beijing) Pharmaceutical Co., Ltd. Energy Policy: "Quality as the top priority, through technical, behavioral, human consciousness, continuously reduce the rate of energy consumption in product value, benefit the users, and promote company development". Good awareness of energy conservation is required, participate in energy saving actions, and assist in the continuous development of the energy management system.
  • “以药品质量为第一要务，通过技术手段，行为规范，人为意识，不断降低产品价值中的能耗比重，造福广大用户，促进企业发展”要求每位员工具有良好的节能意识，积极的节能行动，协助能源管理体系的持续开展

➤ Actively propose energy-saving projects

积极提出节能方案

➤ Coordinate and support the development of energy-saving projects and give positive feedback

协调并支持节能项目的制定，积极反馈意见

➤ Coordinate and participate in the implementation of energy-saving projects

协调并参与节能项目的执行

➤ Participate in internal audit of energy management system

• 参与能源管理体系的内部评审

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。

• Soft skill: Good communication and collaboration.

通用技能: 良好的沟通与合作能力。

• Technical skill: Must be a committed "quality" professional with knowledge of regualed quality systems within the pharmaceutical or related industry.

专业技能: 必须具备制药或相关行业的质量体系的“质量”专业知识经验。

• Education: At least a bachelor degree in pharmacy or chemistry or biology disciplines （or Licensed Pharmacist qualification）

教育背景:至少药学或化学或生物学或相关专业大学本科学历(或执业药师资格)。

• Languages: Fluent English in verbal & written.

语言要求: 熟练的英语书写及沟通能力。

• 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。