GCP Auditor – Freelance

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

📋 Description

• Strategize, prepare, execute, document, and follow up on various types of GCP audits while adhering to quality standards and timelines.

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

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

• Lead and perform both internal and external GCP audits.

• Conduct audits of service providers and GCP systems.

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

• Execute GCP mock inspections in compliance with Competent Authority standards.

⛳️ Requirements

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

• Demonstrated experience in conducting and leading internal and external GCP audits for diverse stakeholders.

• Proven experience in performing a variety of service provider audits, including full-service CRO, biostatistics, data management, and phase I audits.

• Background in executing GCP systems audits.

• Experience 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.

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

• Capability to conduct remote audits.

🏝️ Benefits

• Up to 40% travel.

• Ability to conduct remote audits.

• A supportive and collaborative work environment.

• Encouragement for professional growth.

• An opportunity to make a significant impact in the pharmaceutical and biotechnology sectors.

• A collaborative team of specialists in clinical research, pharmacovigilance, and quality consulting.