Job Description

Our Team/ Overview 我们的团队

The Site Quality department plays a critical role in ensuring that Sanofi's manufacturing sites produce safe, effective, and high-quality products that meet all regulatory requirements and patient needs. Their mission is to maintain the highest quality standards throughout the manufacturing and testing process while supporting continuous improvement and operational excellence.

工厂质量部门在确保赛诺菲生产基地生产安全、有效和高质量的产品方面发挥着至关重要的作用，这些产品需满足所有法规要求和患者需求。其使命是在整个生产和检测过程中保持最高质量标准，同时支持持续改进和卓越运营。

Main Accountabilities 主要职责

• Is responsible of the delivery the microbiology quality control lab aspects of the project, within the allocated budget, schedule and the expected objectives, performances, HSE, Quality. Ensure the project is performed according to the Sanofi Standard and Good Practices. 

负责在预算、进度及预期目标、绩效、HSE和质量范围内交付项目的微生物质量控制实验室相关工作。 确保项目按照赛诺菲标准和良好实践执行

• Participation in the establishment, qualification and commissioning of the Microbiology QC laboratory in IFB. 

参与IFB微生物质量控制实验室的建立、确认和调试。

• Implementation of microbiology tests as part of the DS, incoming material, in-process controls, clean utility monitoring and cleaning validation of insulin drug substance manufacturing.  

对原液、进厂物料、中间产品、公用系统及胰岛素药物制造的清洁验证实施微生物检测。

• Implementation of environment monitoring and gas monitoring for the InsuLINK Facility. 

实施胰岛素项目设施的环境监测和气体监测。

• Support of microbiology method transfers and verification/validation activities. 

支持微生物学方法转移及验证/确认活动。

• Executing microbiology testing and data review in a timely manner, ensuring adherence to the committed scheduled plans.

及时执行微生物检测和数据审查，确保遵守承诺的计划 

• Performing the microbiology data review of executed tests in a timely manner, ensuring adherence to the committed scheduled plans.

 及时对已执行检测进行微生物学数据审查，确保遵守承诺的计划。

• Conscientious documentation of all measurement results, raw data and calculations according to cGMP and data integrity requirements. 

根据cGMP和数据完整性要求，认真记录所有测量结果、原始数据和计算。

• Participation in the preparation and review of laboratory specifications, methods, procedures, templates, protocols and reports. 

参与实验室质量标准、方法、程序、模板、协议和报告的起草与审核。

• Implementation of equipment (re-)qualifications under supervision. 

在监督下实施设备确认与再确认。

• Calibration and maintenance of the assigned equipment or coordination of it, e.g. by external service providers, including the associated documentation. 

协助校准与维护指定设备的，例如：由外部服务提供商提供，包括相关文档。

• Ensuring that he/she is trained and qualified to the assigned microbiology testing that requires to be qualified.

确保接受适当的培训并具备相应的微生物检测资格。  

• Assist in troubleshooting and investigating microbiology issues. 

协助排查和调查微生物学问题。

• Receiving, storing, documenting, handling, and disposing of reagents, biological indicators, culture media, strains, and lysates, while managing their stocks and other testing-related consumables to ensure adequate supply; including inactivation of material with growth. 

接收、储存、记录、处理和处置试剂、生物指示剂、培养基、菌株和鲎试剂，同时管理其库存及其他检测相关消耗品，以确保充足供应，包括活菌类物质灭活。

• Maintenance of documents, e.g. form sheets, test instructions, SOPs, SOP attachments, Logbooks. 

文件维护，例如：表格、测试指导、标准作业程序（SOP）、作业程序附件、日志本。

• Performing his/her tasks in accordance with cGMP and HSE requirements, and with the associated instructions, procedures, records, related to these tasks.

  按照cGMP和HSE要求执行其任务，并遵守与这些任务相关的指示、程序和记录

• Informing his/her manager of any quality (change control, deviations, LI) or HSE event in a timely manner to ensure investigation and impact assessment are performed appropriately.

  及时通知其经理任何质量事件（变更控制、偏差、LI）或HSE事件，以确保调查和影响评估得到妥善执行。

• Executing assigned CAPAs related to remediation plans, continuous improvements.

  执行与整改计划、持续改进相关的指定CAPA。

• Execute other works which is assigned by the line manager. 

执行由直属经理分配的其他工作。

Additional Accountabilities 额外的职责

1. Quality Department HSE Responsibilities

➤ Responsible for following the company’s HSE policy and integrated all requires into daily job.

➤Incorporate HSE work into the work plan

➤ Organize the implementation of HSE management target plan of this department, implement HSE rules and regulations, HSE operation procedures and HSE technical action plan.

➤Regularly carry out to identify HSE potential hazards and develop action plan and finish on time.

➤Timely working out of employee opinions.

➤Actively cooperate with HSE management to prevent accidents happens.

➤ Regularly carry out +QDCI meetings at all levels considering HSE8 requirements. Feedback HSE issues in a timely and accurate manner and actively implement remediation.

➤Participate in the investigation for accidents, analyze the root causes of accidents from the quality management perspective, and related CAPA.

➤Responsible for design annual department PASS plan and ensure implementation as planned.

质量部门HSE职责

➤ 负责遵守公司HSE政策，并将所有要求融入日常工作

➤ 将HSE工作纳入工作计划

➤ 组织实施本部门HSE管理目标计划，执行HSE规章制度、HSE操作规程和HSE技术行动计划

➤ 定期开展HSE潜在危害识别，制定行动计划并按时完成

➤ 及时处理员工意见和建议

➤ 积极配合HSE管理工作，预防事故发生

➤ 根据HSE8要求，定期在各层级开展+QDCI会议，及时准确反馈HSE问题并积极落实整改

➤ 参与事故调查，从质量管理角度分析事故根本原因，并制定相关CAPA

➤ 负责制定部门年度PASS计划并确保按计划实施

1. 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.

➤ Actively propose energy-saving projects

➤ Coordinate and support the development of energy-saving projects and give positive feedback

➤ Coordinate and participate in the implementation of energy-saving projects

➤ Participate in internal audit of energy management system

赛诺菲（北京）制药有限公司能源政策

"质量为先，通过技术、行为、人员意识的提升，持续降低产品价值中的能耗比率，造福用户，促进公司发展"。要求具备良好的节能意识，参与节能行动，协助能源管理体系的持续发展。

➤ 积极提出节能项目建议

➤ 协调和支持节能项目的开发，并给予积极反馈

➤ 协调并参与节能项目的实施

➤ 参与能源管理体系内部审核

• About you 任职资格:

List here ideally the must-haves criteria to be successful on the role.

 Experience 

• Degree in Microbiology/Pharmacy/Biology or Equivalent. 
• Associate degree at the minimum. Preferably bachelor or above. 
• Experience in microbiology quality control, including knowledge of Good Manufacturing Practices (GMP) and regulatory requirements 
• Experience in cleanroom environment monitoring is an advantage.
• Experience in strain identification is an advantage.
• Experience in bacterial endotoxin test for kinetic method or rFc is an advantage. 
• Experience in carrying out equipment qualification or method validation/verification/transfer is an advantage. 

Soft Skills: 

• Ability to drive and embrace change 
• Cross-functional collaboration 
• Precise, independent and structured way of working 
• Proactive Problem-Solving and communication 

Technical Skills: 

• Experience in the field of typical microbiology test (bioburden, bacterial endotoxin), environment monitoring and gas monitoring.  
• Ability to analyse data and laboratory results to make informed decisions
• Keen attention to detail to ensure accuracy in testing, reporting, and compliance with regulatory requirements  

Languages: 

• Academic English/German proficiency is an advantage  
• Mandarin proficiency required (listening, reading and writing)

请列出胜任该职位所必须具备的条件。

• 微生物学/药学/生物化学学位或同等学历。
• 理想情况下是学士，最低大专学位。
• 具备微生物质量控制的经验，包括GMP和法规需求。
• 最好具备洁净区环境监测的经验。
• 最好具备菌种鉴定的经验。
• 最好具备细菌内毒素动态检测方法或rFc的经验。
• 最好具备设备确认、分析方法验证和确认的经验。

软技能：

驱动和拥抱变革的能力。

跨职能协作。

准确、独立和有计划的工作。

主动问题解决和沟通能力。

技术技能：

具备微生物学检测（生物负荷、细菌内毒素）、环境监测和气体监测领域的经验。

能够分析数据和实验室结果，做出明智决策。

注重细节，确保测试、报告的准确性和合规性。

语言:

英语/德语学术能力是优势。

要求普通话能力（听、读、写）。

英语/德语学术能力是优势。

要求普通话能力（听、读、写）。

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