Clinical QA Audits Specialist

About this job

What your responsibilities will be Plan and conduct audits of CROs, vendors, investigator site audits. Assess compliance with applicable regulations and standards. Conduct internal audits of Clinical GCP processes for adherence to SOPs, company policy, and regulations/standards. Contribute to the review of the internal procedures related to the planning, conduct and oversight of clinical audits. Prepare audit reports and discuss findings with auditees and internal customers. Track and follow up on the resolution of audit findings. Provide guidance to Clinical staff in resolving audit findings in a compliant manner. Assist internal groups in preparing for inspections by regulatory agencies and participate in on site regulatory inspections as appropriate.…

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