Australia GxP Auditor – On-Site Compliance & CAPA

Tigermed; Australia; Híbrido; AUD 120.000 - 160.000; Jornada completa

Descripción de la vacante

Tigermed in Australia is seeking a Local GxP Audit Lead to independently conduct on-site and remote audits for Phase I–IV trials within the local base. You will manage the full audit lifecycle, ensure compliance with ICH-GCP, FDA, EMA, TGA, draft concise English reports, document management, CAPA follow‑up, and stay informed on regulatory updates.

The role requires at least 5 years of hands-on GxP audit experience in Australia, strong communication skills, and a relevant life sciences degree;

Formación

• Minimum 5 years hands-on clinical trial/GxP audit experience.
• Solid local audit experience in Australia.
• Proficient in ICH-GCP, FDA, EMA, TGA and global GxP standards.
• Business fluent in English; Chinese proficiency preferred for coordination.
• Bachelor’s degree or above in a medical/pharma field.

Responsabilidades

• Independently conduct on-site and remote GxP audits in Australia.
• Lead pre-audit preparation, on-site execution, finding documentation and closure.
• Draft professional English audit reports with findings and risk classifications.
• Track CAPA actions and verify effectiveness.
• Stay updated on GxP and regulatory policies in the resident region.

Conocimientos

GxP audits

ICH-GCP

Regulatory compliance

Audit reporting

CAPA management

English report writing

Stakeholder communication

Educación

Bachelor’s degree in life sciences or related field

Descripción del empleo

Tigermed in Australia is seeking a Local GxP Audit Lead to independently conduct on-site and remote audits for Phase I–IV trials within the local base. You will manage the full audit lifecycle, ensure compliance with ICH-GCP, FDA, EMA, TGA, draft concise English reports, document management, CAPA follow‑up, and stay informed on regulatory updates.

The role requires at least 5 years of hands-on GxP audit experience in Australia, strong communication skills, and a relevant life sciences degree;