Companies you’ll love to work for

Correlation Ventures
176
companies
2,927
Jobs

M&S-QA Specialist(Operation)-Beijing

Synthorx

Synthorx

Quality Assurance
Beijing, China
Posted on Wednesday, August 30, 2023

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?

  • Providing quality oversight for GMP pharmaceutical product manufacturing related activities 对GMP药品生产相关活动进行质量监督

1. Review routine manufacturing, environmental monitoring and quality control data for in-process and finished products; review and record all batch related documentation timely, assist in release of finished product and ensure that following requirements have been met

审阅涉及中控和成品的日常生产、环境监测和质量控制数据;及时检查并记录所有与批次相关的文件,协助完成产品的放行并确保满足以下要求:

a) All the necessary checks and tests have been performed.

完成所有必要的检查和测试。

b) All necessary production documentation has been completed and endorsed by qualified personnel and is in compliance with Sanofi quality policy, local regulatory and GMP requirements. 所有必要的生产文件均由合格且认可人员完成,符合赛诺菲质量政策,当地法规和GMP要求。

c) Changes or deviations in manufacturing or quality control have been notified and evaluated in accordance with a well-defined system before any products is released.

在任何产品放行前,已根据明确定义的系统通知和评估生产或质量控制方面的任何变更或偏差。

2. Provide quality assurance oversight by performing routine walk-throughs and inspections on Production, Engineering, Supply Chain and other areas assigned where the business is responsible to ensure that all aspects of operations comply with cGMP legal and regulatory requirements as well as Global Guidelines. Escalate timely, follow up and support the completion of related actions.

通过对生产、工程、供应链和业务相关的其它区域进行例行巡视和检查以提供质量保证监督,从而确保运营的所有方面均符合cGMP法律和法规要求以及总部准则。及时上报,跟进并支持完成相关措施。

3. Lead deviation investigations by demonstrating a high level of independent judgment and discretion in the timely identification, investigation and resolution of deviations potentially impacting the quality of products and processes; provide support and advice during cross functional investigations and when required; participate in devising sampling procedures and directions for recording and reporting quality data; review deviation reports and ensure investigations were performed in accordance with established procedures and GMP requirements, and ensure deviations are completed timely .Participate in the initiation of corrective and preventative actions, support CAPA implementation and review CAPA effectiveness.

主导偏差调查,在及时识别、调查和解决可能影响产品和过程质量的偏差方面,表现出较高的独立判断力;在跨职能调查期间以及在需要时提供支持和建议;参与制定取样计划和方法以记录和报告质量数据;审查偏差报告并确保其按照既定程序和GMP要求进行了调查,并确保及时完成偏差。

参与发起纠正和预防措施,支持CAPA的实施并检查CAPA的有效性。

4. Lead product quality review and ensure the PQR is completed following relevant procedures and GMP requirements timely.

主导产品质量审核,确保PQR按照相应程序和GMP要求及时完成。

  • Developing, implementing and maintaining the corporate Quality Management System

发展、实施和维护企业质量管理体系

1. Complete personal trainings according to individual annual training plan and other training requirements. Conduct training in aspects related to pharmaceutical product manufacturing, Quality Management Systems and GMP.

根据个人年度培训计划和其他培训完成个人培训。进行有关药品生产,质量管理体系和GMP方面的培训。

2. Draft, review and revise SOPs and any other site/product related documents ensuring adequate levels of documentation and compliant to existing procedures.

起草、审阅和修订SOP和任何其它与工厂/产品有关的文件,以确保文件水平足够并符合现有流程。

3. Participate in regular quality audits of the site; support on-site audits conducted by external providers; evaluate audit findings and participate in the implementation of appropriate corrective actions.

参与工厂的定期质量审计;支持外部现场审计;评估审核结果并参与执行适当的纠正措施。

4. Participate in qualification and validation management activities, including those covering equipment, processes, methods, and API/excipients/primary packaging materials/critical supplies specifications etc.; review related documents. Support the review and implementation of Change Controls.

参与确认和验证管理活动,包括涉及设备、工艺、方法和API /辅料/内包材/关键物料规格等的活动;审查相关文件.支持变更控制的审阅与实施。

5. Complete other duties as designated by the superior.

完成上级指派的其它工作。

What you should have?

Education / Experience

教育背景/经验

  • At least a bachelor’s degree in pharmacy, chemistry or biology disciplines with minimum 3 years’ experience in drug quality control and /or quality assurance

至少药学或化学或生物学或相关专业大学本科学历,至少3年药品QC或QA工作经验

  • Knowledge of analytical chemistry and/or microbiology prefer

具备分析化学和/或微生物知识优先

Technical skills & Competencies / Language

技能&能力/语言

  • Must be a committed “quality” professional with knowledge of regulated quality systems within the pharmaceutical or related industry

具备药学或相关工业领域质量系统相关专业知识

  • Knowledge of Chinese pharmaceutical rules is mandatory as well as basic knowledge of international GMP

须具有中国药品管理知识及国际GMP的基本知识

  • Good command of written and spoken English

具备良好的英语书写和表达水平

  • Good communication skills

良好的沟通能力

  • Stress tolerance

能够耐受压力

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.