工艺/清洁验证工程师 上海

月薪： 0.8-1.5万/月

该公司所有职位
  • 无工作经验
  • 招2人
  • 01-27 发布

职位描述

岗位职责?负责工艺/清洁验证工作。?负责工艺/清洁验证管理规程的制定及修订。?负责制定工艺/清洁验证主计划。?开展／审核验证前的风险评估。?负责验证方案和验证报告等验证文件的编制/审核.?负责工艺特征研究方案和报告的审核。?组织／协调清洁验证的有序进行。?参与验证过程中偏差的调查分析及变更的评估。任职要求?本科以上学历，生物学和药学相关学科。?3年以上制药或者验证工作经验，包括1年以上工艺验证工作经验。?熟悉CFDA， FDA ，欧盟以及ISPE PDA等法规指南对于验证的要求。?优秀的英语听说读写能力，熟练计算机使用。?有较强的分析问题能力及良好的沟通技巧、工作认真、细致，具有良好的团队合作精神。Job responsibilities：?Responsible for process/cleaning validation.?Responsible for SOP preparation for process/cleaning validation.?Responsible for writing the process/cleaning validation master plan.?Prepare/review risk assessment before validation.?Develop/Revise validation protocols and validation summary reports.?Responsible for reviewing the process characterization studies protocols and reports.?Organize／coordinate validation execution.?Participate in deviation investigation, analysis and change assessment.Requirements：?Bachelor Degree above, major in biology or pharmacy.?At least 3 years of working experience in pharmaceutical or validation, including at least 1 years of process validation.?Familiar with the requirement of validation according to the regulations and guidelines of CFDA, FDA, and EU etc.?Excellent spoken and written English. Good at computer software.?Excellent communication, problem-solving, and organization skills, attentive, careful and meticulous, and strong team-work skill. 职能类别： 生物工程/生物制药

联系方式

郭守敬路

公司信息

Regents Facility Engineering Co., Ltd.上海锐臻洁净科技有限公司Incorporated in 2005, Regents provides Engineering, Construction Management, Validation and GMP Consultancy Services to China's Pharmaceutical Industry in accordance with International GMP Codes and Engineering Guidelines. Over the years, we have served many multinational pharmaceutical companies as well as local firms in their capital projects.锐臻成立于2005年，按照国际GMP规范和工程技术指南为在中国的制药企业提供设计、施工管理、验证和GMP咨询服务。在过去的几年中，我们为许多跨国制药企业和本地公司的新建及改扩建项目提供了技术服务。 We strive to provide extraordinary services to our clients and attract talents to help us grow and achieve our goals. The key to our success are our people, who possess vast experiences with our major global pharmaceutical customers and partnering engineering companies.我们致力于为顾客提供卓越服务，并吸引业界才俊与我们共同成长。我们的员工在与跨国公司客户以及工程公司合作的过程中积累了大量的实践经验。The difference we make for our customers are based on solutions that increase efficiency, drive growth and manage risk. By applying our diverse competencies, deep knowledge and dynamic talent, we help our customers build and qualify their facilities as efficiently and cost effective as possible.我们的优势在于为顾客提高生产效率、促进成长、降低风险。我们凭借丰富的专业知识和充满活力的工程师团队协助顾客以高效率， 低成本的方式建设及验证生产设施。Our customers rely on us because they can - from our knowledge and technical expertise, to our staff stability and many years track record of success. Regents gets the job done.我们的顾客信赖我们的知识、专业技能，稳定的员工团队和数年来的成功记录。锐臻值得您的信任。Website: https://www.regentsfe.cn; https://www.regentsfe.com公司详情请登录https://www.regentsfe.cn或https://www.regentsfe.com

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