GCP Auditor – Freelance

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

📋 Description

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

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

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

• Organize and oversee inspection readiness activities for GCP process inspections at both sponsor and investigator locations.

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

⛳️ Requirements

• Bachelor’s degree in Life Science is preferred.

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

• Familiarity with conducting various service provider audits (e.g., full-service CRO, biostatistics, data management, phase I).

• Experience in executing GCP systems audits.

• Expertise in coordinating and managing 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.

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

🏝️ Benefits

• Remote work options available.

• Potential for up to 40% travel.

• A supportive and collaborative work environment.

• Encouragement for professional growth.

• Opportunity to significantly impact the industry.

• Collaboration with esteemed pharmaceutical and biotechnology firms.

• A passionate and collaborative team of experts specializing in clinical research, pharmacovigilance, and quality consulting.

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