Quality Control Specialist

6 days ago


lucknow, India beBeeClinicalAudit Full time

Job OverviewClinical site auditors ensure compliance and quality at clinical trial sites by conducting audits, reviewing documentation, and verifying adherence to protocols, Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and regulatory requirements.Conduct thorough audits of clinical research sites across various phasesReview case report forms, informed consent documents, and regulatory filesIdentify and document audit findings; recommend corrective actionsSupport site staff with compliance guidance and training initiativesPrepare comprehensive audit reports and follow up on Corrective Action Preventive Actions (CAPA) implementationKey Qualifications:Bachelor's degree in a life science or related fieldExtensive experience in clinical research, auditing, and Quality Assurance (QA)In-depth knowledge of GCP, International Conference on Harmonisation (ICH) guidelines, and FDA/EMA regulationsStrong communication, analytical, and organizational skillsAbility to travel required


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