Quality Assurance Auditor (审科员,质量保证) (R1114997) in Beijing, China at IQVIA™

Date Posted: 1/28/2020

Job Snapshot

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Job Description

Q2 Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. With a relentless focus on quality and innovation, Q2 Solutions uses its global experience and scientific expertise to transform science and data into actionable medical insights that help customers improve human health.  A joint venture of IQVIA (formerly QuintilesIMS) and Quest Diagnostics, Q2 Solutions combines the best of each parent organization’s clinical trials laboratory services capabilities to fulfill its mission of treating each sample as if a life depends on it.

  • Plan, schedule, conduct, report and close assigned audit activities in any of the countries involved with IQVIA contracts to

assess compliance with applicable regulations/guidelines, customer requirements, IQVIA SOPs and project specific guidelines/instructions.

  • Conduct quality assurance activities and projects for clients according to IQVIA 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.
  • Represent quality assurance program on customer and project teams under the direction of more senior QA staff.
  • 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 action plans associated with customer audits
  • Enhance and maintain a working knowledge of relevant GXP regulations

Job ID: R1114997