GCP Auditor Fresher's job

• Support the strategic development of an effective global risk-based audit strategy and program for clinical trials.
• Conduct of quality reviews of protocol, reports in addition to audit of tables, figures and listings and other supplementary clinical trial documentation.
• Conduct external site and vendor audits and provide support in preparation, review and finalization of audit reports.
• Draft QA (Quality Assurance) SOPs (Standard Operating Procedures). Review and provide QA inputs for functional SOPs.
• Continued maintenance of clinical QA systems with written standard operating procedure (SOPs).
• Provide support in local and global Health Authority (HA) inspections and third party audits.
• Review, evaluate and approve proposed corrective and preventive action plans (CAPA) in collaboration with the responsible business unit.
• Maintain database of quality issues reported to QA.
• Perform timely management of audit metrics
• Coordinate training management for clinical development and support in uploading role specific training on Learning Management System.
• Maintenance of vendor management database.
• Support for implementation of Data Management System (DMS) and continual maintenance
• Coordinate archive management.
• Assist in management of controlled documents.

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