Senior Life Sciences Auditor - Remote Freelance

Lifelancer Ltd; United States; À distance; USD 83 000 - 124 000; Plein temps

Résumé du poste

ProPharma is seeking experienced freelance life sciences auditors based in Japan to support client audit activity on a project-based contractor basis. Senior quality, compliance, clinical research, pharmacovigilance, PMS, GVP, GPSP, and GMP professionals who have hands-on audit experience in Japan are invited to apply.

Work may be onsite, remote, or hybrid depending on assignment. Assignments are freelance contractor, not permanent staff; deadlines, client needs, and auditor availability

Qualifications

• Proven audits in pharmaceutical, biotech, CRO, vendor, or clinical research environments.
• Strong knowledge of Japanese quality expectations in at least one audit area.
• Experience producing audit reports and managing findings with CAPA.
• Ability to work independently on project-based audits.
• Native-level Japanese and business-level English.

Responsabilités

• Plan, conduct, and report audits per regulations and client procedures.
• Audit clinical research, pharmacovigilance, PMS, GVP, GPSP, GMP and related areas.
• Review processes, quality systems, vendor oversight, and controls.
• Identify findings, assess risk, and prepare audit reports.
• Support follow-ups, CAPA reviews, and client communications.
• Engage with auditees and clients; may include onsite work in Japan.

Connaissances

Audit experience

Life sciences

Japanese language

English communication

Independent contractor

Description du poste

ProPharma is seeking experienced freelance life sciences auditors based in Japan to support client audit activity on a project-based contractor basis. Senior quality, compliance, clinical research, pharmacovigilance, PMS, GVP, GPSP, and GMP professionals who have hands-on audit experience in Japan are invited to apply.

Work may be onsite, remote, or hybrid depending on assignment. Assignments are freelance contractor, not permanent staff; deadlines, client needs, and auditor availability