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理化QC专员
8-15K/月北京市-北京/本科及以上/3-5年
白依璇一周前来过
山西招才猫人力资源有限公司

职位详情

岗位职责

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
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

工作地点

    亦庄经济技术开发区兴盛街7号
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公司信息

某医药公司

  • 上海
  • 1000-9999人
  • 生物技术
  • 外企
  • 已上市
赛诺菲是一家世界500强外资企业,全球领先的医药健康企业,1982年,赛诺菲进入中国。经过30余年的发展,赛诺菲目前在中国拥有9,000名员工,11家区域办事处,3家生产基地,主要业务涵盖制药和人用疫苗,是国内增长最快的医药健康企业之一。   在不一Young的赛诺菲,你可以收获:   新技能Get √ -赛诺菲大学的国际化课程,享受直线经理的一对一指导,私人定制的能力模型,只等你来!   新幸福Get √ -和蔼的Leader,逗趣的伙伴,幸福感爆表的团队,100%的员工关怀,只等你来!   大平台Get √ -全球前四的医药健康企业,10,000名员工遍布100多个国家。大平台,人才广,资源多,只等你来!   新红牛Get √ -晋升政策,财务挽留计划,有竞争性的工资,有吸引力的奖金及全面的福利计划,只等你来!
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