M&S-Batch Release & PCU Lead 产品放行和生产制作QA主管-Hangzhou

Job title职位名称: Batch Release & PCU Lead  产品放行&生产制作质量主管

• Location工作地点： Hangzhou Site 杭州工厂

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：

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

• Responsible for the batch release, providing QA oversight to ensure that manufacturing stages of the product complies with cGMP and Sanofi global requirement and standard requirements.
• QA监督，确保产品制作阶段满足GMP、赛诺菲全球总部的要求和标准要求。

Activities具体职责

• Perform oversight for manufacturing steps, include Gemba, inspection, investigation etc.
• QA监督，包括现场Gemba、检查、调查等。

• Overseeing the batch release process to ensure compliance with regulatory requirements and company standards. Reviewing and approving batch records and associated documentation. Ensuring all batch release activities comply with Good Manufacturing Practices (GMP).
• (GMP)。

• Conducting risk assessments and implementing mitigation strategies for batch release processes.

• Coordinating with production, quality control, and supply chain departments to ensure timely batch release.

• Investigating and resolving any issues or deviations related to batch release (including temperature excursion evaluation per product in case distribution channel face an unusual event).

• Participating in internal and external audits and inspections.

• Collaborating with regulatory affairs to ensure compliance with local and international regulations.

• Monitoring and analyzing batch release performance metrics.

• Implementing continuous improvement initiatives to enhance batch release efficiency and effectiveness.

• Participating in Quality Alert/Product alert meetings and ensuring that investigation and actions taken during those meetings allow the decision for disposition of lots.
• /产品警报会议，并确保在这些会议期间采取的调查和行动能够做出批次处置的决定。

• Being representative of the site in the CoP led by the global and if requested participating in the CoE and ensure local communication. 
• CoP 中，并根据需要参加 CoE 并确保本地沟通。

• Point of contact within operational team for complaint investigation when needed on site (coordination of investigation report).

• Prepare the product reviewing according to the annual plan, evaluate the product quality trend, decide the products' quality standard, the requirement of producing, controlling program, and validation.

• Gap analysis according to GMP directive and Sanofi global guidance; ensuring on-site quality system complies.
• GMP和赛诺菲总部要求；

• The aim is to drive self-awareness of the quality process and drive the improvement of the maturity of the respective quality system.

• Be responsible for HSE within the scope of his/her responsibility and provide a safe working environment for employees.

• Other assignments.

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:

• Pharmacy or experience in related area.
• 8 years of experience within the pharmaceutical industry, include 1 year of experience of production management, at least 5 years QA work experience, of which a minimum of 3 years should be in on-site QA operations.  
  • 8年制药行业工作经验，包括1年生产管理工作经历，至少5年QA工作经历，且应包括3年以上现场QA工作经历。
• Strong knowledge of Good Manufacturing Practices (GMP) and quality assurance principles.
  • (GMP) 和质量保证原则。

• Soft skill:
  通用技能：office software（熟练应用办公电脑软件)
• Technical skill:
  专业技能: Pharmacy or related field  (药学或相关领域)

• Ability to meticulously review batch records and documentation to ensure accuracy and compliance with regulatory standards.
• Proficiency in analyzing batch release performance metrics and identifying areas for improvement.
• Capability to investigate and resolve issues or deviations related to batch release processes efficiently.
• Experience in managing multiple tasks and projects simultaneously, ensuring timely completion of batch release activities.
• Ability to analyze complex data and identify trends, issues, and solutions.
• High level of accuracy and attention to detail in all quality assurance activities.
• Strong verbal and written communication skills for effective interaction with team members, and regulatory bodies.
• Proficiency in identifying problems and implementing effective corrective actions.
• Ability to manage multiple projects simultaneously, ensuring timely completion and adherence to quality standards.

• Education:
  教育背景: Bachelor’s degree above本科以上学历
• Languages:
  语言要求: English speaking, reading and writing  (英语口语、阅读和书写良好)

Why choose us? 为什么选择我们？

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
• 14 周的性别中立育儿假。

PursueProgress. Discover Extraordinary. 进无止境，探索菲凡

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. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

进步离不开人——来自不同背景、身处不同地点、扮演不同角色的人们，都怀揣着一个共同的目标：创造奇迹。你也可以成为这样的人。追逐变革，拥抱新理念，探索我们提供的一切机遇。让我们携手进步，共同发现非凡。

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
在赛诺菲，我们为所有人提供平等的机会，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。

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

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。