Senior QA Auditor - GCP Audits
Core
Plan and conduct independent clinical (GCP) audits to assess compliance with regulations, guidelines, and operating procedures for IQVIA contracts.
Role type
Senior QA Auditor (Clinical/GCP)
Builds
Audit reports, corrective action plans, and quality management system records.
Domain
Pharmaceutical research and development / Clinical trials / Regulatory compliance
Required skills
GCP audits, clinical trial Investigator site audits, Root Cause Analysis (RCA), Corrective Action Prevention (CAPA), Effectiveness Check (EC), eQMS management, regulatory interpretation, process improvement, training delivery, risk analysis
Preferred skills
Clinical study report/data management/biostatistics audits, pharmaceutical R&D processes
Technologies
eQMS, word-processing, spreadsheet, database applications
Responsibilities
Plan, schedule, conduct, report and close audit activities; Evaluate audit findings and prepare reports; Provide consultation to project teams and customers on regulations; Review and approve investigations, RCA, CAPA, and EC plans; Evaluate policies for compliance; Maintain eQMS; Lead QA initiatives; Assist in training new staff; Perform pre-inspection visits and host audits.
Seniority
Senior, hands-on IC