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16683-Sr QA Auditor (R1055417) in Tokyo, JP at IQVIA™

Date Posted: 12/7/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Tokyo, JP
  • Experience:
    Not Specified
  • Date Posted:
    12/7/2018
  • Job ID:
    R1055417

Job Description

Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.

Plan, schedule, conduct, report and close audit activities involved with IQVIA contracts. Audits are conducted to assess compliance with applicable regulations/guidelines, customer requirements, IQVIA SOPs and project specific guidelines/instructions.
Evaluate audit findings and prepare and distribute reports to operations staff, management, and customers.
Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures.
Provide consultation to customers and monitors in interpretation of audit observations and formulation of corrective action plans.
Prepare and review and approve corrective action plans
Present educational programs and provide guidance to operational staff on compliance procedures.
Conduct quality assurance consultancy activities and projects for clients within budget and established timelines.
Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.
Host customer audits,
Assist in hosting mock regulatory inspections and regulatory facility inspections by acting as scribe and/or reviewing documents and identifying and calling operational staff to answer questions as needed.
Ensure proper conduct of customer-initiated audits and mock regulatory inspections, and assist in regulatory facility inspections.
May perform GLP Archivist duties where needed.
Assist in training of new Quality Assurance staff.

We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes. Whatever your career goals, we are here to ensure you get there! We invite you to join IQVIA™



Job ID: R1055417