长沙招聘

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 REQUIREMENTS

Skills

·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.

    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、合肥等省会城市；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： *****************

接收简历邮箱：hr@rg-pharma.com（邮件主题：城市+岗位名称+本人姓名）

【子公司】苏州海科医药技术有限公司为诺思格（北京）医药科技股份有限公司的子公司，子公司成立于2015年01月14日，地址位于苏州工业园区裕新路108号4楼，经营范围包括生物技术开发、生物检测技术服务、会务服务，详情请登录公司主页：*******************************/

【子公司】南京艾科曼信息技术有限公司，专攻于临床研究领域中的数据管理和统计分析环节，全面移植美国CRO的质量标准及管理体系，一步到位与国际CRO行业接轨。同时，服务质量获得欧美主要药厂的认证。自成立以来已完成300余项临床项目，其中部分已经获得美国FDA及欧洲EMEA通过。率先使用国际标准数据管理系统，所有高管均有在美国相关行业从业10年以上经验。总部位于北京，在上海、南京、成都、武汉、合肥等省会设有办公室。