Summary
Date Posted: Monday, May 13 2024, Base Salary: Not Disclosed

JOB DETAILS:
Participate in planning and budgeting of the GCP inspections within the division
Conduct GCP inspections for authorized clinical trial sites in the country using risk-based approach.
Submit the GCP inspection findings to internal clinical trial committee for grading of GCP findings
Prepare and submit GCP inspection reports for the inspected clinical trials and follow up on corrective and preventives actions (CAPA)
Maintain and update a database for GCP inspections of clinical trials,
Participate in the development and review of regulations, guidelines, training manuals, SOPs, IEC materials relevant to GCP inspection.
Review and make recommendations for GCP inspection for regulatory actions.
Develop and maintain good relations with customers in matters of good clinical practices inspection.
Demonstrating the ability to consistently provide quality services that meet customer and regulatory requirements within their respective Office/Department/Division/ or Unit to meet Rwanda FDA quality objectives.
Participating in organized training in Quality Management System.
Doing the assigned tasks (job) by fully implementing the QMS established requirements.


Work Hours: 8

Experience in Months: 36

Level of Education: Bachelor Degree

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