GCP Auditor – Freelance

This is a fully remote position, open to applicants in New Zealand.

📋 Description

• Develop, organize, execute, document, and follow up on various types of GCP audits in accordance with expected quality and timelines.

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

• Implement GCP quality assurance projects on behalf of pharmaceutical and biotechnology client organizations.

• Lead and perform both internal and external GCP audits.

• Execute audits of service providers and GCP systems.

• Organize and oversee activities in preparation for GCP process inspections.

• Conduct GCP mock inspections adhering to Competent Authority standards.

⛳️ Requirements

• Bachelor's degree in Life Science is preferred.

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

• Background in conducting various service provider audits, including full-service CRO, biostatistics, data management, and phase I studies.

• Experience with GCP systems audits is required.

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

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

• Capability to perform remote audits.

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

🏝️ Benefits

• Employees have the option to work remotely.

• Travel requirements may reach up to 40%.

• A supportive and collaborative work environment.

• Opportunities for professional growth and development.

• Chance to make a significant impact within the industry.

• A passionate and collaborative team of experts.

• A diverse and inclusive workplace where every voice is valued.