Auditor - Quality Assurance

1 week ago

bangalore, India beBeeClinicalResearch Full time

Compliance Assurance SpecialistA Clinical Site Auditor is required to ensure adherence to regulatory standards and maintain quality at Clinical Trial sites.Carry out audits of clinical research sites across phases I–IV, evaluating compliance with GCP, ICH guidelines, and FDA/EMA regulations.Analyze CRFs, informed consent forms, and regulatory documents for accuracy and completeness.Identify and report audit findings, recommending corrective actions to site staff.Provide guidance and training on compliance procedures to site personnel.Prepare comprehensive audit reports and follow up on the implementation of corrective actions.Requirements:Bachelor's degree in a life science or related field, such as nursing, pharmacy.Minimum 10-12 years of experience in clinical research, with a focus on auditing and QA.Strong understanding of GCP, ICH guidelines, and FDA/EMA regulations.Excellent analytical, communication, and organizational skills.Ability to travel is essential for this role.

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    bangalore, India Comviva Full time

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