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Advarra

Advancing clinical research: safer, smarter, faster

Pharmaceutical Quality GCP Auditor – Consulting

AuditorAuditorPart TimeRemoteLeadTeam 501-1,000Since 1983H1B No SponsorCompany SiteLinkedIn

Location

Japan

Posted

7 days ago

Salary

0

Seniority

Lead

Bachelor Degree10 yrs expEnglishJapaneseGoogle Cloud Platform

Job Description

Pharmaceutical Quality GCP Auditor – Consulting

Advarra

• Conduct Good Clinical Practice (GCP) audits (planning, agenda, physical or remote audit, and report writing) • Evaluate investigator sites, CROs, and vendor compliance or qualification. • Prepare comprehensive audit reports detailing findings and root-causes. • Provide written audit reports in English. • If required will provide corrective actions support and present findings to QA leadership and stakeholders • Work collaboratively with clients to ensure quality standards.

Job Requirements

  • Minimum 10+ years of Clinical Quality Assurance and/or Good Clinical Practice (GCP) experience.
  • Minimum 5+ years of Good Clinical Practices auditing experience.
  • Demonstrated experience with regulatory agency expectations (e.g., FDA, EMA) and audit readiness activities.
  • Demonstrated experience in developing and implementing quality assurance plans, audit programs, and corrective action plans.
  • B2 level in English communication, verbal and written
  • B2 level in Japanese communication, verbal and written
  • Bachelor's degree

Benefits

  • Flexible work arrangements
  • Professional development opportunities

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