Auditor

1 week ago


kochi, India beBeeQuality Full time

Job Title: Quality Assurance and Compliance SpecialistDescription:Ensure the integrity of clinical research by conducting thorough site audits, reviewing documentation, and verifying adherence to protocols and regulatory requirements.Develop and implement effective quality assurance strategies to identify and mitigate risks across all phases of clinical trials.About this role: We are seeking a seasoned Quality Assurance Auditor with expertise in GCP, ICH guidelines, and FDA/EMA regulations. The ideal candidate will have a strong understanding of clinical research operations, audit procedures, and quality management systems.Key Responsibilities:Conduct on-site audits at clinical research sites to ensure compliance with protocols, Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and regulatory requirements.Review and verify accuracy of Case Report Forms (CRFs), informed consent forms, and regulatory documents.Identify and report audit findings; recommend corrective actions to site staff and management.Collaborate with cross-functional teams to develop and implement quality assurance initiatives that promote compliance and quality improvement.Requirements:Bachelor's degree in life sciences, nursing, pharmacy, or related field.10-12 years of clinical research experience, with a focus on auditing and quality assurance.Strong knowledge of GCP, ICH guidelines, and FDA/EMA regulations.Benefits: Competitive salary, comprehensive benefits package, and opportunities for professional growth and development.


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