GCP Auditor (Freelance)
Core
Planning, conducting, and reporting Good Clinical Practice (GCP) audits for pharmaceutical and biotechnology companies to ensure regulatory compliance and patient safety.
Role type
Senior GCP Auditor (Freelance/Contractor)
Builds
Compliance assurance and inspection readiness for clinical research organizations and sponsors
Domain
Life Sciences / Clinical Research / Regulatory Compliance
Deliverable
client delivery
Required skills
GCP audit execution, regulatory requirement interpretation, service provider audit management, systems audit, inspection preparation coordination, mock inspection facilitation, national and international GCP legislation knowledge
Preferred skills
Life Science degree, Competent Authority standard mock inspection experience
Technologies
N/A
Responsibilities
Planning and preparing GCP audits, executing audits based on regulatory requirements, performing GCP quality assurance projects, coordinating inspection preparation activities, conducting GCP mock inspections
Seniority
Senior, hands-on IC
