QA Auditor

Responsibilities:Plan, execute, and document GCP audits of clinical sites, CROs, vendors, Trial Master Files (TMFs), and internal quality systems.Conduct vendor qualification and periodic requalification audits.Assist with GLP, GMP, and quality system audits as needed.Develop and maintain audit documentation, including audit plans, reports, findings, and closure records.Evaluate audit responses, root cause investigations, and Corrective and Preventive Action (CAPA) plans.Confirm the timely implementation and effectiveness of corrective and preventive actions.Ensure compliance with applicable GCP, GLP, GMP, FDA, ICH, and other regulatory standards.Assist with regulatory inspection preparation and inspection-readiness activities.Provide quality and compliance support to cross-functional teams.Support continuous improvement initiatives and maintain quality assurance procedures and documentation.Perform additional duties as assigned.Scroll down for a complete overview of what this job will require Are you the right candidate for this opportunityQualifications:Bachelor's degree in Life Sciences, Pharmacy, Nursing, Chemistry, Biology, or a related scientific field.Minimum of five years of Quality Assurance experience within the biotechnology, pharmaceutical, or clinical research industry.At least three years of GCP auditing experience, including clinical sites, CROs, and vendors.Working knowledge of ICH GCP guidelines, FDA regulations, and clinical quality systems.Experience with CAPA management, root cause analysis, and risk-based auditing practices.Strong written and verbal communication skills. xhyhwjd Excellent organizational, analytical, and problem-solving abilities.