高级稽查员（Senior QA Auditor） 北京

月薪： 10-15万/年

该公司所有职位
  • 3-4年经验
  • 本科
  • 招3人
  • 11-09 发布
  • 五险一金
  • 补充医疗保险
  • 交通补贴
  • 餐饮补贴
  • 通讯补贴
  • 绩效奖金
  • 年终奖金
  • 股票期权

职位描述

职位描述： QA Activities·Plan, schedule and perform internal, client and vendor audits and reviews as required in order to assure that clinical studies managed by R&G PharmaStudies are of the highest standard and in compliance with the requirements of R&G PharmaStudies or Sponsor SOPs, study protocols and GCP.·Evaluate significance of audits findings and coordinate the findings responses with functional departments and/or study teams.·Manage processes for internal non-compliance corrective action plans.·Be responsible for the development of Quality Management System from the GCP perspective, which includes writing, reviewing, updating and promoting SOPs and any other associated documentation and deploying quality related systems.·Review and recommend new or changes to existing SOPs and systems to reflect current company and industry practice.·Develop audit checklists, plans and agendas of audits for QA internal and external audits.·Assist in or host client audits and/or health authority inspections.Training Activities·Provide training to internal staff and/or investigational site staff on regulatory requirements, compliance standards, and quality initiatives in preparation of regulatory inspection.·Provide GCP compliance training, audit and inspection readiness training.Advisory and Supporting·Advise on and prioritize the training needs of Clinical Operation staff in liaison with Training staff and the Clinical Operation team.·Liaise with Clinical Operations, MA, RA, DM, SA, SMO and Pharmacovigilance to assist in interpretation and application of GCP requirements.·Provide on-going support to clinical project managers on compliance and quality issues.MINIMUM REQUIREMENTSSkills·Demonstrated effectively balance quality and speed in complex situations.·Demonstrated ability to work in a team environment.·Demonstrated ability to work under pressure and requires minimal supervision.·Strong interpersonal and communication skills.·Strong analytical skills.·Excellent planning and organizational skills.·Excellent oral, written and presentation skills.Education·Bachelor degree or above in Clinical Medicine/Pharmacy/Biological Sciences or equivalent.Language Skills·Competent in written and oral English.Work Experience·Minimum of 3-year experience in pharmaceutical/medical device industry and preferred having experience in clinical operations and project management. Minimum 1 year working experience in compliance/quality control/quality assurance.·Working experience in developing or rolling out training programs.·Thorough knowledge of drug development process.·Detailed knowledge of ICH-GCP Guidelines and regulations. 职能类别： 临床研究员

联系方式

北京市

公司信息

诺思格（北京）医药科技股份有限公司是国内专业领先，规模较大的临床研究合同组织（CRO）之一，总部设在北京，办事处设在上海、长沙、广州、武汉、成都、西安、哈尔滨、南京、沈阳、天津、长春、杭州等省会城市；在国内覆盖60余个城市，在亚洲覆盖6个国家与地区，已与200余家机构，450余家医院及600多个科室合作，目前已为260多位国内外客户提供国际标准的临床研究外包服务。业务涵盖新药评估与咨询、注册事务、临床试验实施、数据管理和统计分析、医学事务及培训等全方位服务。 “服务医药 服务健康”，详情请登录公司主页： www.rg-pharma.com 接收简历邮箱：hr@rg-pharma.com

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