GCLP Auditor – CAP CLIA Experience Required

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

📋 Description

• Plan, prepare, conduct, report, and follow up on various types of GCLP audits, including CAP CLIA.

• Execute audits grounded in a thorough understanding of regulatory requirements and Good Clinical Laboratory Practice (GCLP).

• Implement GCLP quality assurance initiatives for pharmaceutical and biotechnology client organizations.

• Coordinate and oversee inspection preparation activities for GCLP process inspections at both sponsor and investigator locations.

• Carry out GCLP mock inspections in accordance with Competent Authority standards.

⛳️ Requirements

• A BSc in Life Science is preferred.

• Proven experience in conducting and leading both internal and external GCLP audits, including CAP CLIA, for diverse stakeholders.

• Demonstrated experience in performing a variety of service provider audits.

• Background in executing GCLP systems audits.

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

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

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

• Capability to conduct audits remotely.

🏝️ Benefits

• Opportunity for up to 40% travel.

• Ability to perform remote audits.

• Supportive and collaborative work environment.

• Encouragement for professional growth.

• Chance to make a significant impact across the industry.

• Join a collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.