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生化QC专员
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12-22万 北京 本科 3-5年 招聘 1 人 预计佣金 5.7K 07:08发布
72小时新发
JD基本信息
岗位职责
Our Team我们的团队: Manufacturing & Supply consists of 3 manufacturing platforms based on global business units, as well as supporting functions of Quality, Market Supply and Strategy. We are committed to making best class medicines with excellent strategies and tools and delivering them to our patients. 制造与供应事业部包含以3个全球事业部为基础的制造平台,以及质量、供应商、精益战略等支持部门。致力于用优异的战略和工具制造优质的药品并传递到患者手中。 Main responsibilities职责描述: To carry out Pharmaceutical analysis technical support in Physical chemistry, biochemistry, microbiology including but not limited to method validation/verification/transfer, HA authority technical support, testing in compliance with analytical methods/protocols/specifications, follow good documentation practices, CGMP, safety health and environmental. 在理化,生化,微生物方向提供药物分析技术支持,包括但不限于方法验证/确认/转移,官方机构技术支持,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. Prepare method familiarisation, validation, verification, and transfer protocols in accordance with project timelines, execute testing per protocol, and generate corresponding reports. Draft method and specifications. 依据项目进度撰写方法熟悉、验证、确认、转移方案并依据方案进行试验并出具对应报告。起草方法及质量标准。 Attend project meetings, oversee lab deliverables, manage timelines/budgets, and ensure cost efficiency. 参加项目会议,管控实验室项目进度,节点跟踪及预算,确保资源高效利用。 2. 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; 3. Take assigned 5S responsibilities. 执行5S分配任务。 4. 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 5. 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。 6. Execute other works which is assigned by superior. 执行上级分配的其他工作。 7. 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。 8. 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 method development/validation/transfer experience in biologic drug product. 经验:从事过2年以上生物药方法开发验证转移工作。 • Soft skill: Good at communication, problem solving oriented, strong self-learning capability. 通用技能: 善于沟通,问题解决,自主学习能力强。 • Technical skill: Have Pharmaceutical analysis experience in Physical chemistry, biochemistry or Microbiology, preferably in biochemistry. 专业技能:具有生化或微生物药物分析实验工作经验,生物化学分析方向优先。 • Education: related disciplines such as chemistry, biochemistry, pharmacy, microbiology etc. Bachelor degree or above. Master degree is preferred. Candidates from domestic top-tier universities or with study-abroad experience in English-speaking countries will be given preference. 教育背景:化学、生物化学、微生物学、药学等相关专业。本科或以上学历(硕士优先)。优先考虑国内外顶尖院校毕业生。 • Languages: Good at English writing, reading, listening and spoken. 语言要求:英语听说读写良好。 • Play to Win Behaviours: 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
所属行业:
制药
职能分类:
药品生产/质量管理
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
职位要求
学历要求:
本科·统招
工作年限:
3-5年
技能/证书:
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薪资福利
年薪范围:
12-22万*12薪
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不可以接受