GCP Auditor

Japan Permanent Foreign Multinational
  • Work in a World-winning Global CRO
  • Lead GCP Consulting Program to Global Healthcare Clients

About Our Client

  • Award winning global CRO company, with expertise in oncology, immunology, infectious disease, cardiovascular disease areas

Job Description

  • Plan and conduct GCP audits in the Medical Device, Biological Drug/Agent, and/or Pharmaceutical realm.

  • Audits may include investigator site, sponsor, Mock Inspection, process, quality assurance/quality management system, software/computer system qualification and validation, vendor (including vendor qualification), and/or bioanalytical/bioequivalent/pharmacokinetic.

  • Report Observations and other potential concerns to the auditees and client, both through verbal presentations and written audit reports as required by the client.

  • Assist with the development of corrective and preventive action plans, and facilitate resolution of audit findings as required by the client.

  • Write confirmation letters, and audit plans, agendas, reports and other required audit documentation.

  • Provide drafts of required documents, and finalize following internal QA and sponsor reviews according to project timeline.

  • Provide GCP and inspectional preparedness training to clinical sites, vendors, and sponsors as required by client.

  • Provide good documentation training to auditees as required by client.

  • Perform gap analysis of SOPs and procedures as required by client.

  • Review, develop and revise client procedures, guidance documents, form templates, and quality documentation as required by client.

  • Perform all audit-related activities in accordance with company procedures and using company document templates, or client procedures and templates as required by the client.

The Successful Applicant

  • Bachelor's degree or higher in biomedical, nursing or related life science discipline required.

  • Minimum 5 years relevant auditing experience preferred.

  • Minimum 2 years SOP development experience preferred.

  • Minimum 2 years GxP training experience preferred.

  • Comprehensive understanding of ICH Guidelines [i.e., ICH E6 (R1) and ICH E6 (R2)], appropriate EU Directives, appropriate Titles within 21 CFR, and relevant country-specific regulations.

  • Training to and understanding GDPR requirements relative to clinical research preferred.

  • Excellent demonstrated verbal and written communication skills

  • Ability to travel up to 50%, both domestically and internationally.

What's on Offer

  • Work in an international environment, clear career development opportunities, contribute to global clinical studies
  • Work from home options available across Japan
Ed Marsden
Quote job ref
Phone number
+813 6832 8981

Job summary

Job Type
Consultant name
Ed Marsden
Consultant phone
+813 6832 8981
Job Reference
Company Type