GCLP Auditor (Freelance - CAP/CLIA experience required)
Core
Planning, conducting, and reporting GCLP audits (CAP/CLIA) for pharmaceutical and biotechnology companies to ensure regulatory compliance and quality standards.
Role type
Senior GCLP Auditor (Freelance/Contract)
Builds
Audit reports and compliance assessments for client companies
Domain
Life Sciences / Clinical Research / Regulatory Compliance
Deliverable
client delivery
Required skills
GCLP audit execution, CAP/CLIA regulatory knowledge, internal and external audit leadership, service provider auditing, GCLP systems auditing, inspection preparation coordination, GCLP mock inspection facilitation, national and international GCLP legislation expertise
Preferred skills
BSc in Life Science, Competent Authority standard mock inspection experience
Technologies
None stated
Responsibilities
Planning, preparation, conduct, reporting, and follow-up of GCLP audits; executing audits based on regulatory requirements; performing quality assurance projects; coordinating inspection preparation activities; conducting GCLP mock inspections
Seniority
Senior, hands-on IC
