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 (GCP)
Builds
Compliance reports, corrective action plans, and audit findings for pharmaceutical research and development processes.
Domain
Life sciences / Clinical research / Regulatory compliance
Deliverable
client delivery
Required skills
GCP audits, clinical trial Investigator site audits, Root Cause Analysis (RCA), Corrective Action Prevention (CAPA), Effectiveness Check (EC), eQMS management, regulatory interpretation
Preferred skills
Clinical study report audits, data management audits, biostatistics clinical trial audits, pre-inspection visits, mock regulatory inspections
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 and CAPA plans; Evaluate policies for compliance and recommend improvements; Assist in training new Quality Assurance staff; Perform pre-inspection visits and host audits/inspections
Seniority
Senior, hands-on IC
