Quality Assurance Auditor

3 weeks ago

Tirupati, 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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