M&S-QA Specialist-Beijing

Job Information职位信息

Job title职位名称: QA Specialist /QA 专员

• 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: permanent employee 长期员工
• Site/Unit 区域/事业部：Beijing site  北京工厂

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：

As a QualiPSO CMS Business Owner 作为QualiPSO 系统CMS 流程专家

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.

Document Control and Quality Assurance: 文档控制和质量保证

• Oversee the local document control processes within QualiPSO CMS.
• QualiPSO CMS中的本地文档控制流程。
• As a Document Management Specialist, ensure compliance with document management standards and regulatory requirements. The main responsibilities include ensuring local document compliance, continuous improvement of document formats and content management, and ensuring 100% in place in use of GAP analysis for documents at the local level.
• 文件管理专员，确保符合文档管理标准和法规要求，主要内容是确保本地文件的合规，文件格式和内容管理的持续改进，确保文件的GAP分析100% 完成，在本地有效实施且持续改进。

Stakeholder Management: 相关方管理

• Act as the primary point of contact for QualiPSO CMS matters at the local level. Liaise between local users, IT support, and the global QualiPSO team.
• QualiPSO CMS事务的主要联系人，在本地用户、IT支持和全球QualiPSO团队之间进行联络。

System Access and Security: 系统访问和安全

• Manage local user access rights and permissions within QualiPSO CMS.
• QualiPSO CMS中的本地用户访问权限和权限。
• Ensure proper implementation of role-based access control (RBAC) for data security.
• RBAC）以保障数据安全。

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。

Knowledge Management: 知识管理

• Maintain and update local QualiPSO CMS documentation, including job aids and standard operating procedures.
• QualiPSO CMS文档，包括工作辅助工具和标准操作程序。
• Contribute to the QualiPSO knowledge base and share best practices with the wider community.
• QualiPSO知识库做出贡献，并与更广泛的社区分享最佳实践。

As a Deviation & CAPA Business Owner 作为本地偏差&CAPA 流程专家

Deviation Management 偏差管理

• Lead the identification, investiga tion, and resolution of deviations in local processes.
• Utilize QualiPSO to create, manage, and track deviations.
• QualiPSO 创建、管理和跟踪偏差。
• Ensure compliance with Sanofi's global quality standards and regulatory requirements.

CAPA Implementation 纠正和预防措施（CAPA）实施

• Develop and oversee Corrective and Preventive Action (CAPA) plans.
• CAPA）计划。
• Coordinate cross-functional teams to implement CAPA measures effectively.
• CAPA 措施。
• Monitor CAPA progress and ensure timely closure of actions.
• CAPA 进展并确保及时完成行动。

QualiPSO System Expertise

• Serve as the local expert for QualiPSO,System.Deviation & CAPA.
• QualiPSO系统偏差和CAPA的本地专家
• Provide guidance on deviation and CAPA processes to team members and stakeholders.
• CAPA 流程方面的指导。
• Ensure proper documentation and traceability of quality events.

Process Improvement 流程改进

• Analyze trends in deviations and CAPAs to identify areas for process improvement.
• CAPA 趋势，识别流程改进领域。
• Develop and implement strategies to prevent recurrence of quality issues.
• Contribute to the continuous improvement of local quality management processes.

Training and Support 培训和支持

• Conduct training sessions on deviation management and CAPA processes.
• CAPA 流程的培训课程。
• Offer support and mentorship to team members on quality-related activities.
• Stay updated on changes in quality procedures and communicate updates to relevant parties.

Compliance and Reporting 合规和报告

• Ensure local deviation and CAPA processes align with Sanofi's global standards and regulatory requirements.
• CAPA 流程符合赛诺菲全球标准和法规要求。
• Prepare and present quality metrics and reports to management.
• Participate in audits and inspections related to deviation and CAPA processes.
• CAPA 流程相关的审核和检查。

Collaboration and Communication 协作与沟通

• Liaise with global quality teams to ensure alignment of local processes with corporate standards.
• Collaborate with cross-functional teams to address quality issues effectively.
• Communicate quality-related information clearly to various levels of the organization.

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

User Management 用户权限管理

• Administer user accounts, roles, and permissions within QualiPSO for local users
• QualiPSO中的用户账户、角色和权限
• Process and approve access requests for various QualiPSO modules (e.g., Deviation/CAPA, Content Management, Third Party Risk Management)
• QualiPSO模块（如偏差/CAPA、内容管理、第三方风险管理）的访问请求
• Ensure appropriate access levels are granted based on user roles and responsibilities
• According to the requirements of the Global group and regulations, conduct regular reviews of system permissions

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

Artwork & Shade Card management Artwork包装设计及封样卡管理

Artwork Quality Approval 包装设计质量批准

• Review and approve packaging artwork, ensuring compliance with Sanofi's global standards and local regulatory requirements

Shade Card Management 封样卡管理

• Oversee the development and maintenance of shade cards for product packaging
• Ensure color consistency across different batches and production runs
• Collaborate with suppliers to maintain color standards and quality
• Correctly utilize the Globalvision inspection software to complete the inspection of new version shade cards and generate inspection reports.
• Globalvision 检测软件完成对新版封样卡的检测，并生成检测报告
• Based on the inspection results, carry out the approval, distribution, retrieval, and destruction of the proof cards.

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。

• Experience: At list with minimum 5 years experience in pharmaceutical production and /or quality assurance.

工作经验:至少5年药品生产或质量保证工作经验。

• 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。

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!