• 招聘类型：社招
• 工作性质：全职
• 热招：热招活动

职位描述

To carry out QC microbiological analyses in compliance with analytical methods, ensuring quality, good documentation practices, cGMP, safety health and environmental standards are well met.

按照分析方法进行微生物有关实验，确保符合质量、文件记录和GMP以及环境/安全/健康的要求。

To establish and maintain standard operating procedures, specification, analytical methods and to perform the equipment qualification, calibration, analytical method validation.

建立和维护标准操作规程，质量标准，检验方法并执行设备校验与验证及分析方法验证。

1. To carry out Sampling, Analytical testing and Reporting of API, raw materials, active ingredients, packaging materials, in process samples, intermediates, finished products and, as well as the monitoring of utility and environment according to the test methods GMP requirements.

按照分析方法和GMP的要求进行原辅料、包材、中控样品，以及成品的取样，检验及报告。执行公用工程介质和环境监控

2. To Ensure that analyses are carried out on time and are in compliance with the specifications. Participate to the OOS investigations and the quality assessment.

确保样品及时检验并符合质量标准的要求。参与超标结果的调查以及产品质量评估

3. Perform analytical transferring / validation and the preparing of stability test protocol and reports for the new products.

分析方法转移及验证，为新产品准备稳定性试验方案

4. To maintain the availability （including the calibration）of instrument together with supplier and maintenance technician.

与设备厂家及维护工程师一起确保检验设备的正常状态及校准状态

5. To carry out the maintenance/calibration of laboratory equipment in compliance with the established schedules and maintain accurate records and documentation of the maintenance/calibration.

按计划对实验室仪器进行维护、校准并准确记录和存档

6. To assist the supervisor on writing draft sops, draft qualification protocols of the analytical instruments and the analytical methods. Perform the qualification work.

协助主管编写标准操作规程、仪器确认方案及分析方法。进行验证工作

7. Perform gap analys for global requirement and local authority standard.

总部要求及本地法规标准的差距分析。

8. To be the back up of the other analysts to achive the team target.

其它分析员缺席时，作为替补以完成团队目标。

9. Be engaged in the lab continuousely improvement for technical and management perpurse. Advocate and execute the sms concept and practice.

参与实验室管理及技术的持续改善活动。倡导和实施赛诺菲管理系统。

10. Quality Department HSE Responsibilities质量部HSE职责

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

负责贯彻公司HSE的有关规定，把公司HSE制度的措施贯彻到每个具体环节。

• Incorporate HSE work into the work plan

将HSE工作纳入工作计划中。

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

组织实施本部门HSE管理目标计划，落实HSE规章制度、HSE操作规程和HSE技术措施计划。

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

定期开展本部门HSE隐患排查治理工作，制定整改计划并按时完成隐患整改。

• Timely working out of employee opinions.

负责部门级HSE教育与考核工作

及时处理员工提出的意见。

• Actively cooperate with HSE management to prevent accidents happens.

积极配合HSE管理工作，防止各类事故的发生。

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

定期开展本部门各级+QDCI会议，结合HSE8要求，及时、正确填写和反馈各类HSE问题，并积极落实整改。

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

参加事故调查分析工作，从质量管理角度分析事故原因，提出事故防范措施。

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

负责制定年度部门PASS计划，并按进度组织实施。

11. 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.

赛诺菲（北京）制药有限公司能源方针：“以药品质量为第一要务，通过技术手段，行为规范，人为意识，不断降低产品价值中的能耗比重，造福广大用户，促进企业发展”要求每位员工具有良好的节能意识，积极的节能行动，协助能源管理体系的持续开展

• Actively propose energy-saving projects

积极提出节能方案

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

协调并支持节能项目的制定，积极反馈意见

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

协调并参与节能项目的执行

• Participate in internal audit of energy management system

参与能源管理体系的内部评审

任职条件

Job Requirements:

1.Bachelor or above degree in Microbiology, Pharmacy or other related fields

2.Familiar with GMP/HSE requirements in laboratory, also pharmacopoeia GMP

3.Good English written and spoken

4.Soft Skills:

• Display passion
• Exercises good judgment & drives change for competitive advantage
• Drives for superior results & has passion to win
• Inspires continuous improvement & breakthrough thinking, display analytical &conceptual thinking.
• Good communication
• Able to burden pressure, result driven

在赛诺菲，多样性和包容性是我们如何运作和嵌入核心价值观的基础。我们认识到，要真正挖掘多样性所带来的丰富多彩，我们必须以包容为先导，并拥有一个工作场所，在那里，这些差异可以茁壮成长，并被利用起来，让我们的同事、患者和客户的生活更丰富多彩。我们尊重和颂扬我国人民的多样性、他们的背景和经验，并为所有人提供平等的机会。

职位要求

• 学历要求：无
• 工作经验：无
• 外语要求：不需要