M&S-Qualification & Validation Lead-Hanagzhou

Job Information职位信息

Job title职位名称: Qualification & Validation Lead

•    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

职务描述
Generic一般

Be responsible for site validation, maintenance validation system to ensure that the validation procedure comply with Current GMP (Chinese GMP &EU GMP)requirement and global directive requirement.
工厂验证工作，确保并维护验证体系和验证过程符合现行GMP(中国GMP和欧盟GMP)和总部Directive要求。
Participate in the validation and qualification activities of new project in Hangzhou site.
参与工厂新项目涉及的验证和确认工作。
Implement and monitor quality system for quality third party management. Ensure quality system running effectively, compliance to CGMP and Sanofi global requirement.  
执行和监督质量体系的运行，负责质量第三方管理，确保该质量体系被有效运行，符合现行GMP和赛诺菲总部要求。 

KEY ACCOUNTABILITIES 关键职责
1.负责验证体系的维护和改进

•   Responsible for validation systems maintenance and improvement

•    建立和定期更新验证主计划，并根据VMP追踪验证的实施情况
•    Prepare and update site validation master plan and tracing validation execution status in terms of VMP.
•    验证支持和URS/验证文件的审核
•    Validation support and URS/ validation document review
•    在验证的标准操作程序中定义验证的策略，职责和验证的文件，确保验证符合中国和欧盟GMP要求和总部的质量要求。
•    Define the strategy; responsibility and document of the validation in the standard operation procedure to ensure that validation comply with the Chinese GMP and EU GMP requirement and global quality requirement.
•    组织协调相关部门进行验证活动 .
•    Organize with the related department to perform validation activities
•    审核验证文件并参与以下的验证活动：
•    Review validation document and participate in the validation activities below
•    生产工艺验证（包括存放周期验证） 
•    Process validation （include bulk holding time validation）
•    设备验证（包括生产设备、公用系统和实验室设备）
•    Equipment qualification (include manufacture equipment , utility , facility and QC instrument)
•    分析方法验证
•    Analytical method validation
•    计算机控制系统验证
•    Computerized system validation
•    清洁验证
•    Cleaning validation
•    运输验证等
•    Transportation validation and so on
•    负责清洁验证的执行和实施，协调供应链，生产和QC部门配合完整清洁验证活动。
•    Be responsible for the conduction and execution for cleaning validation, coordinate the PSC , production and QC to achieve the activity together.
•    配合上游工厂完成相关的运输验证活动，完成阶段性的运输验证报告,支持杭州工厂中间体的放行工作。
•    Coordinate the upstream site to complete the shipping validation, and finish the interim report to support the release of IPC in Hangzhou site.
•    负责欧盟产品的运输验证和运输风险评估工作
•    Be responsible for shipping validation and risk assessment of EU production.
•    负责质量部项目涉及的验证和确认的管理，如新厂房，公用系统等。确保项目的验证工作的GMP 符合性。
•    Take the responsibilities for projects on validation & qualification of the quality department，Such as new premise and new HVAC. Ensure the implementation of GMP readiness part of the project.
•    作为实验室计算机化设备（色谱系统）的实验室管理员进行日常的管理（权限回顾，系统配置设置等）
•    Take the responsibility of lab computerized equipment（Empower system） manager for the routine management.（review for access control , Empower system configuration.）
•    作为审计专家, 组织和参与工厂内部和供应商的审计工作。
•    As a audit leader expert , organize and take part in the audit, including Hangzhou site and supplier.
•    Management of third parties: establish the procedure for the third party management, which includes management of the supplier profile, audit request and evaluation of the audit, establishment of quality agreement, and annual performance evaluation of the approved suppliers. Review the material quality information.  
2.第三方管理 3rd party management：
•    建立供应商管理程序；管理供应商档案；提出审计需求并进行审计评估；起草质量协议；对已批准的供应商进行年度绩效评估；审核物料质量信息。 
•    Communicate with internal site for the related material defect identified in the site manufacturing. Draft and coordinate the signature of quality agreement with internal sites. 
•     与集团内部工厂沟通生产过程中所识别的物料缺陷；起草并协调集团内部供应商质量协议的签订 
•    Maintenance of QSMP. Including drafting, updates, and archiving.  
•    QSMP 维护（起草，更新，存档） 
•    Third Party Change Notification process management.  
•    供应商变更通知流程管理 
•    Third Party Complaint  process management.  
•    供应商投诉管理 

3.Oversight of Computerized system management to ensure it complies with GMP requirements.
对计算机化系统的管理进行监督，确保符合GMP要求。

4.Other assignments.
领导安排的其它工作；

5.Be accountable for providing a safe work environment and maintaining HSE performance for his/her area and activities.  
对自己职责范围内职业健康安全环境工作全面负责。

6.The designated Primary Process Owner (PPO) is responsible for the assigned Quality Maturity Index (QMI)/Quality System Standard.
负责指定的质量成熟度指数（QMI）及质量体系标准。

7.PPO is responsible for assessing quality processes, review assessment and making remediation actions with the Site Leadership Team;
负责质量流程评估，与工厂管理层一起审核评估结果并制定所需的改进措施；

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。

Education / Experience
Must have: 最低要求
Education教育: University (本科)
Professional /Major专业: Pharmacy or experience in related area
药学相关专业或相关领域工作经验
Experience 经验:  N/A
Better to have: 优先考虑项
Education教育:  Postgraduate (研究生)
Professional /Major专业：Pharmacy or related field  (药学或相关领域)
Experience 经验: More than five years validation work experience in Pharmaceutical company, prefer foreign enterprise work experience （在药厂超过五年的验证的工作经验，特别是在外企的工作经验

Technical skills & Competencies / Language
Must have : 最低要求
Technical 技能:  N/A
Language语言:  English reading and writing  (能使用英语阅读和书写)
IT Skill电脑技能:  office software（熟练应用办公电脑软件)
Other Ability其他能力: Team work spirit (团队工作的精神)

Better to have : 优先考虑项
Technical 技能:  Familiar  to cGMP  (熟悉现行GMP)

Language语言: Good at English reading, writing, listening and speaking（良好的英语听、说、读、写能力）
IT Skill电脑技能: Senior(高级)
Other Ability其他能力：Good communication and transversally cooperation（良好的沟通协调能力）

Behavioral Competencies (LEAD and others)

Must to have : 最低要求
•    Stretch to beyond 超越自我
•    Take action 主动出击
•    Patients Focus 患者为中心
•    One Sanofi 组织为先

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。