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 while adhering to expected quality standards and timelines.

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

• Implement GCP quality assurance projects for clients in the pharmaceutical and biotechnology sectors.

• Conduct and oversee internal, external, service provider, and GCP systems audits.

• Organize and manage activities in preparation for GCP process inspections at sponsor and investigator sites.

• Perform GCP mock inspections in accordance with Competent Authority standards.

⛳️ Requirements

• A Bachelor’s degree in Life Science is preferred.

• Proven experience in conducting and leading both internal and external GCP audits for various stakeholders.

• Background in performing service provider audits, including those for full-service CROs, biostatistics, data management, and phase I studies.

• Experience in carrying out GCP systems audits.

• Skilled in coordinating and managing inspection preparation activities for GCP process inspections at sponsor and investigator locations.

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

• Capable of conducting remote audits.

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

• Experience with GCP mock inspections in line with Competent Authority standards is a considerable advantage.

🏝️ Benefits

• Option for remote work.

• Opportunities for professional development and growth.

• A supportive and collaborative work atmosphere.

• Chance to make a significant impact within the life sciences industry.

• Collaborate with esteemed pharmaceutical and biotechnology companies.

• Up to 40% travel involved.