JD基本信息
岗位职责
Main responsibilities职责描述:
To carry out QC analyses in compliance with analytical methods/protocols/specifications, follow good documentation practices, CGMP, safety health and environmental.
按照分析方法/方案/标准进行理化实验,遵守良好文件记录和GMP以及环境/安全/健康的要求。
Specifically, 具体为
1. According to the test methods/protocols/specifications to carry out analytical testing for samples of semi-finished products, finished products, API, excipients, packaging material, cleaning validation/verification and pharmaceutical water, etc..
按照分析方法/方案/标准对半成品,成品,原辅料,包材,医疗器械,制药用水,清洁验证/确认等样品,执行分析检验;
2. Perform the sampling of raw materials, active ingredients, packaging materials, imported bulks, cleaning validation/verification and pharmaceutical water.
负责原料、辅料、包装材料、进口半成品、制药用水的和清洁检测擦拭取样;
3. Lab related SAP data maintenance.
实验室相关SAP数据维护;
4. Ensure that analyses are carried out in time. Execute lab investigations and the quality assessment.
确保样品及时检验。执行实验室调查以及产品质量评估;
5. 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;
6. Carry out the maintenance of laboratory equipment according to the established schedules and maintain accurate records and archive.
按计划对实验室仪器进行维护并准确记录和存档;
7. (Assist and) draft of work related SOPs, testing record template, qualification protocols/reports of the analytical instruments and the analytical methods. Perform the qualification work.
(协助)编写工作相关的标准操作规程、检验记录模板,仪器确认方案/报告及分析方法,并进行相关验证工作;
8. Print and manage lab related logbook.
打印管理实验室相关logbook。
9. Assist GAP analyses between global requirement and local authority standard.
协助完成总部要求及本地法规标准的差距分析。
10. Pay attention on the number of available reagents, column, reference standards and other testing relates consumables ensure proper amount can be used. Manager archives of columns.
关注可用的试剂、色谱柱、对照品及其他检测相关耗材确保有足量可用。并管理色谱柱档案。
11. Provide technical support to official testing.
对官方检测提供技术支持。
12. Perform activities related with Medical Device according to the current Good Supply Practice (GSP) regulations.
依据现行经营管理规范(GSP)执行医疗器械相关活动。
13. Take assigned 5S responsibilities.
执行5S分配任务。
14. Perform activities related with Medical Device according to the current Good Supply Practice (GSP) regulations. 依据现行经营管理规范(GSP)执行医疗器械相关活动
15. Engaged in the lab continuously improvement of technical and management purpose. 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。
16. Execute other works which is assigned by superior.
执行上级分配的其他工作。
17. HSE responsibilities HSE职责:
Proactively response to HSE management works to prevent each type of accident, and proactively propose HSE related feedbacks or advices.
积极配合HSE管理工作,防止各类事故的发生,积极提出HSE 相关反馈或意见。
18. 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
任职要求
• Experience: Have Pharmacy GMP lab working experience.
具有药厂GMP实验室工作经验
• Soft skill: Communication, problem solving oriented. as well as a good knowledge of Chinese and international GMP are required.
通用技能: 沟通,问题解决, 善于解决问题的能力和主动性。
• Technical skill: a good knowledge of Chinese and international GMP, DI are required.
专业技能: 要求熟悉中国和国际GMP,数据完整性要求。
• Education: related disciplines such as chemistry, biochemistry, pharmacy, microbiology etc.
教育背景: 化学、生物化学、微生物学、药学等相关专业
• Languages: Good at English writing, reading, listening and spoken
语言要求:英语听说读写良好
• Play to Win Behaviors: Stretch; Take Action; Act for Patients & Customers; Think One Sanofi
全力致胜行为: 超越自我, 主动出击, 以患者和客户为本, 团结一致
工作城市:
北京,招聘1人,详细地址:亦庄经济技术开发区兴盛街7号