GCP Auditor – Freelance

This is a fully remote position, open to applicants in New Zealand, +1 more country.

📋 Description

• Strategize, prepare, execute, document, and follow up on various types of GCP audits in alignment with expected quality standards and timelines.

• Carry out audits grounded in a thorough understanding of regulatory standards and Good Clinical Practice (GCP).

• Implement GCP quality assurance initiatives for pharmaceutical and biotechnology client organizations.

• Oversee and coordinate inspection readiness activities for GCP process inspections at both sponsor and investigator sites.

• Perform GCP mock inspections adhering to Competent Authority standards.

⛳️ Requirements

• Proven experience in executing and leading both internal and external GCP audits for a diverse range of stakeholders.

• Background in performing service provider audits, encompassing full-service CRO, biostatistics, data management, and phase I audits.

• Experience in conducting GCP systems audits.

• Proven ability to coordinate and manage inspection preparation activities for GCP process inspections at sponsor and investigator locations.

• In-depth knowledge of national and international GCP laws and guidelines.

• Willingness to travel up to 40% of the time.

• Capability to conduct remote audits effectively.

• A bachelor's degree in Life Science is preferred.

• Experience in conducting GCP mock inspections to Competent Authority standards is a considerable advantage.

🏝️ Benefits

• Up to 40% travel.

• A supportive and collaborative work environment.

• Opportunities for professional development and growth.

• The chance to make a significant impact in the pharmaceutical and biotechnology sectors.

• Join a passionate and collaborative team of experts.

• Work in a diverse and inclusive workplace where every voice is valued.

• Engage in collaborative partnerships.