北京招聘

工作职责:

Under the governance of IQVIA Global QA group and Kun Tuo QA department, complete all trainings required by IQVIA Global QA, and be familiar with IQVIA QA SOPs.

? Attend calls/meetings involving IQVIA Global QA or some of the Global QA team members.

? Plan, schedule, conduct, report and close assigned audit activities involved with Kun Tuo contracts to assess compliance with applicable regulations/guidelines, customer requirements, Kun Tuo SOPs and project specific guidelines/instructions.

? Conduct quality assurance activities and projects for clients according to Kun Tuo departmental or customer policies and procedures within budget and established timelines scheduling, conducting, reporting, and closing audits.

? Assist in preparation and review of corrective action plans.

? Document and report quality and compliance issues to QA management according to required timelines.

? Advise quality assurance management on system audit needs.

? Assist in hosting customer audits, mock regulatory inspections, and regulatory facility inspections by serving as Scribe, reviewing documents and identifying and calling operational staff to answer questions as needed. May host some customer audits independently as directed by QA line management.

? Assist in preparation and review of corrective/preventive action plans associated with customer audits. May review the corrective/preventive actions plans independently as directed by QA line management.

? Enhance and maintain a working knowledge of relevant GCP regulations.

任职资格:

? Knowledge of word-processing, spreadsheet, and database applications.

? Considerable knowledge of GCP regulations and quality assurance auditing techniques, especially good

knowledge and understanding of National Medical Products Administration (NMPA) requirements.

? Fluent English speaking and writing skills.

? Strong interpersonal skills.

? Excellent problem solving skills.

? Effective organization, communication, and team orientation skills.

? Ability to initiate assigned tasks and to work independently.

? Ability to manage multiple projects.

? Ability to establish and maintain effective working relationships with coworkers, managers and clients .

    昆拓信诚医药研发（北京）有限公司是艾昆纬公司投资全资子公司，为美资CRO公司，依托艾昆纬公司全球高标准的质量管理系统和资源，昆拓形成了涵盖所有运营部门的完备标准操作流程（SOP）系统以及质量控制体系。
    昆拓秉承诚信、责任、合作、创新的公司文化，致力于成为中国本土临床研究服务的领跑者，以艾昆纬为依托，用心提供高品质的专业化服务。昆拓具有开放、友好的公司文化氛围，制定了严格的人才培养机制，为员工提供了良好的培训以及职业发展平台。
    人员一经录用，公司将提供富有竞争力的薪酬水平。除去国家规定的五险一金外，公司还给员工提供商业医疗保险和商务旅行保险、年度体检、重大疾病保险及人身意外保障等。