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A Range of Possibilities

QC Specialist

date posted 07/31/2019
contract type Full time
job id R2518410
location China

To carry out analytical testing of API, raw materials, active ingredients, packaging materials, in process samples, intermediates, and finished products, ccording to the test methods and medical device requirements.

按照分析方法及医疗器械的要求进行原辅料、包材、中控样品以及成品的检验;

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;

Perform the sampling of raw materials, active ingredients, packaging materials, in process samples, intermediates, and finished products.

负责原料、辅料、包装材料、中间制程产品、中间体及成品的取样;

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;

Maintain the availability of test equipment 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;

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;

Assist the supervisor by 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;

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。

To be the back up of the other analyst/s.

其它分析员缺席时,作为替补。

Engaed 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。

质量部HSE职责:

➤ 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。

➤ 将HSE工作纳入工作计划中。

➤ 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。

➤ 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。

➤ 负责部门级HSE教育与考核工作;及时处理员工提出的意见。

➤ 积极配合HSE管理工作,防止各类事故的发生。

➤ 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。

➤ 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。

➤ 负责制定年度部门PASS计划,并按进度组织实施。

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

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

支持节能项目的制定,积极反馈意见

➤ Participate in and implement energy-saving projects

参与并实施节能项目

➤ Participate in internal audit of energy management system

参与能源管理体系的内部评审

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.

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Please note you are leaving the corporate site of Sanofi and are being redirected to our applicant tracking system, Workday, which allows you to apply to our open positions.

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