上海相关职位： 医疗器械(IVD)质量管理专员 (职位编号：12) 医疗器械(IVD)临床推广代表(上海地区) (职位编号：21) 医疗器械销售 ***医疗耗材销售代表 医药销售经理 体内动物实验员 医疗器械销售代表 食品检验机构实验室食品检验员 销售经理 医疗设备销售工程师/主管
周边城市招聘： 上海 浙江 安徽 广东 山东 河北 重庆 北京 江苏 湖南
企业入驻日期： 2017-11-09
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无工作经验 -
硕士 -
招1人 -
11-09 发布
职位描述
职位描述： 职位描述： Key accountabilities: 1. Lead the efforts for analytical development studies within ARD department; function as project leader role in analytical development projects. 2. Plan and execute analytical method development and validation for drug substances/drug products; perform sample analyses including but not limited to samples for drug substances /drug products used for clinical trials; 3. Design and review method validation and stability program protocols for both drug substances and drug products where applicable; coordinate the execution of the protocols. 4. Plan, Coordinate, and oversee the work activities of scientific staff within the assigned group. 5. Design, Review and/or approve the formal analytical methods, method validation reports, stability study reports, Certificate of Analysis (CoA), summaries/reports related to analytical research and development works. 6. Be responsible for project management starting from project execution/project following up, regular analytical development update, review and approval of analytical protocols/reports and GMP documents. Assist the interaction with partners by issuing project reports, entertaining on-site visitation and through tele-, web- or video-conferencing etc. 7. Be expected to work closely with supervisor to meet project timelines, departmental goal, and customer requests. Be responsible for improving the operation efficiency and productivity while ensuring the current quality systems in full compliance to all applicable regulatory standards 8. Perform daily management of the analytical labs; conduct the group training in technology and compliance as needed. Requirements: 1. Ph.D. or Master degree in analytical chemistry, pharmaceutical analysis or other directly-related science discipline with experience or training in analytical chemistry, pharmaceutical analysis or equivalent experience. 2. Oversea study or working experience and industrial experience in Analytical R&D field is prefer. 3. Must be well familiar with the requirements of the FDA cGMP/GLP regulations, ICH guidelines and industry trend/practice in analytical development requirement 4. Must be able to coach junior scientists or managers to accomplish performance objectives. 5. Supervisory experience in a pharmaceutical R&D environment in both project and people management is desirable. 6. Strong communication skills, both written and verbal, and outstanding interpersonal skills are essential job requirements. 职能类别： 医药技术研发管理人员 职能类别： 医药技术研发管理人员 生物工程/生物制药 关键字： 医药技术研发 项目管理 项目经理 稳定性研究 药物分析 相容性研究
联系方式
国伟路135号都市工业园区10号楼
公司信息
集团简介： 集团成立于2008年，总部位于上海，在广州、苏州设立分公司，是一家材料与化学领域专业的综合型科技服务商。 集团旗下拥有微谱技术、创化研究院、微析检测、微略咨询四大核心品牌。 业务覆盖材料、化学、环保、食品以及生物医药等多个领域，针对企业在产品研发、质量控制、知识产权中遇到的问题，提供配方分析、产品开发、产品检测、专利申请等综合解决方案。 截至2016年9月，集团拥有全职员工600余人，精密仪器如NMR、Q-TOF、ICP-MS、SEM-EDX、XRF等200余台、建立各类谱图数据库100多万条，实验室获CNAS及CMA资质；并荣获上海市科技小巨人企业、高新技术企业等荣誉称号。已与包括众多500强企业在内的30000多家客户建立了合作，服务地区覆盖中国及多个海外地区。 我们以科技服务改变世界为己任，不断提升技术水平，不断创新服务模式，致力于成为材料及化学领域卓越的世界级科技服务集团。 备注：公司网址：www.weipujishu.com 如果您对我们公司提供的职位感兴趣 也可以发送您的简历至以下邮箱：weipuzhaopin@weiputech.com 邮件主题：姓名 学历 申请职位名称 简历以附件形式上传。我司将尽快与您取得联系
