M&S-Specialist, QS-Shenzhen

Job description

Who we are?

As a global healthcare leader and a Global Top Employer, we are as much a partner to patients facing health challenges as we are a partner to you on your career journey. We are focused on empowering our people to be agents of change, because the work we do will change health outcomes and empower patients’ lives. This is where you will have access to a broad track for all-round development as well as the platform to work as one team across one of the broadest healthcare and well-being portfolios globally.

Why start your career path in Sanofi?

Here, you can:

·  Set clear direction & aligns team & others, around common objectives
·  Inspire continuous improvement & breakthrough thinking, display analytical &conceptual thinking
·  Have broad presence and resources within large platform to broaden global view sight

What you can contribute?

1.日常管理 Operation Management

起草或更新文件管理体系并维持文件管理体系的正常有序运行，保证GxP各项工作都有可依据的标准、有序进行，并确保相应文件始终处于受控及可追溯状态。出现异常及时上报。

Issue or update the documentation management procedure and ensure the normal running and efficiency of document management system to ensure all activities related to GxP are documented clearly to achieve consistent operation and product quality as well as to allow full control and traceability. Timely escalation whenever necessary.

作为质量体系组的团队成员之一，其日常工作应支持QS的业务运营，包括但不限于：

•      支持团队成员起草、更新并维护质量保证管理其他业务流程（如：变更、偏差、CAPA、产品投诉、培训、供应商审计、自检、总部文件本地化等），保证质量管理活动能有序、高效的开展；

•      业务流程的总部文件本地化分析；

•      月度质量相关关键绩效指标的汇报；

•      按既定计划执行自检、供应商审计及培训等。

•      参与法规审计、集团审计及审计准备、协调和后续跟踪工作。

As one of Quality system team members, provide routine activities to support QS business operation, including not limit as following:

•      Provide GMP training to Site staff (including contractors) and responsible for effectiveness assessment.

•     Prepare, update and maintain routine operation of procedures related to quality assurance, (such as change control, deviation, CAPA, product complaint, training, supplier audit, self-inspection, global documentation etc.), ensuring the quality related activities will be complemented in high efficiency and good order.

•      Gap analysis for related business procedure of global documentation.

•      Prepare monthly quality KPIs report.

•      Perform self-inspection, supplier audit and training etc. according to pre-approved plans.

•      Participate in regulatory inspections, GQA audits and audit preparation, coordination and action follow-up.

日常工作职责应确保其符合员工手册的要求，并确保工作场所内所有的活动遵从HSE8的要求。

Ensure HSE8 is followed for all activities within working area;

2. 其它Others

QA经理/质量负责人分配的其它工作。

Other works assigned by QA manager or Quality head.

What you should have?

学历、工作年限(对任职者要求) Specific degree, duration of experience (Required to hold the job): 

•      大学本科或以上学历，持有药学、生物、化学或相关专业学士以上学位为佳。

•      拥有在疫苗/化学制药至少3年的工作经验，生物制药优先。

•      University qualification or above, pharmaceutical and /or biological related background;

•      At least 3 years of relevant experience in the pharmaceutical industry preferably in Biologics.

关键技术能力以及其他软技能Key technical competencies and soft skills:

•      熟悉质量管理体系

•      熟悉风险评估、变更控制、偏差处理等，具有验证和现场监控经验者为佳

•      熟悉GxP和相关法规

•      良好的专业知识基础

•      良好的沟通和协调能力

•      良好的中英文听说读写能力

•      Familiar with quality management system

•      Familiar with risk assessment, change control, deviation handling and so on. Better to have experience in validation and shop floor oversight

•      Familiar with GxP and other regulatory

•      Good professional knowledge base

•      Good communication and coordination skill

•      Good listening, oral, reading and writing skill required both for Chinese and English

If you want to be part of a team that puts patients first, plays to win in digital era with courage, integrity, respect and trust, to inspire your own career journey through a care & collaborate platform, and with special focus on below competency:

·  Exercise good judgment & drives change for competitive advantage
·  Drive for superior results & has passion to win
·  Build the talent pipeline and develop others
·  Able to burden pressure, result driven

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.