Quality Assurance Auditor

3 weeks ago


New Delhi, India K3-Innovations, Inc. Full time

Job Title: Clinical Quality Compliance Manager Location: Bengaluru, Karnataka, IndiaReports To:QA/Compliance Director or Clinical Operations DirectorJob Summary:Clinical Site Auditor to ensure compliance and quality at Clinical Trial sites. You will conduct site audits, review documentation, and verify adherence to protocols, GCP, GLP and regulatory requirements.Key Responsibilities: Conduct audits of clinical research sites across phases I–IV. Review CRFs, informed consent forms, and regulatory documents. Identify and report audit findings; recommend corrective actions. Support site staff with compliance guidance and training. Prepare audit reports and follow up on CAPA implementation.Qualifications: Bachelor’s degree in life sciences, nursing, pharmacy, or related field. 10-12 years of clinical research experience, with auditing and QA experience. Knowledge of GCP, ICH guidelines, and FDA/EMA regulations. Strong communication, analytical, and organizational skills. Ability to travel is required.Preferred: Clinical Research or Quality Auditing certification (ACRP, SOCRA). Experience with eTMF and EDC systems. Experience auditing multi-center or global trials.Working Conditions: Up to 50% travel to clinical sites. Combination of remote, and field work. Flexible schedule to accommodate site audits.



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