GMP Auditor – Freelance

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

📋 Description

• Develop, organize, implement, report, and follow up on various types of GMP audits in accordance with expected quality standards and timelines.

• Carry out audits grounded in a thorough understanding of regulatory requirements and Good Manufacturing Practices (GMP).

• Undertake GMP quality assurance projects for pharmaceutical and biotechnology client companies.

• Organize and oversee preparation activities for GMP process inspections at sponsor and investigator locations.

• Oversee projects to ensure timely provision of deliverables.

• Recognize issues and propose practical solutions.

⛳️ Requirements

• Proven experience in conducting and leading both internal and external GMP audits for diverse stakeholders.

• Background in performing a variety of service provider audits is advantageous (e.g., API manufacturers, CMOs).

• Experience in organizing and managing inspection preparation activities for GMP process inspections at sponsor and investigator sites.

• Comprehensive understanding of current relevant regulatory standards.

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

• Skilled in managing projects and ensuring timely deliverables.

• Capability to identify issues and provide solutions in a practical manner.

• Bachelor’s degree in Life Science is preferred.

• Willingness to travel up to 40%.

• Ability to perform remote audits.

🏝️ Benefits

• Up to 40% travel.

• Capability to conduct remote audits.

• Collaborative team atmosphere.

• Chance to contribute to safe and effective pharmaceutical treatments.

• Work alongside experts in clinical research, pharmacovigilance, and quality consulting.