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 .

上班地址：北京朝阳区广渠路18号院世东国际中心 A 座 11 层（地铁7号线百子湾）