Quality Assurance Auditor

4 days ago


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

Job Title: Clinical Quality Compliance ManagerLocation: 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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