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

JOB DETAILS:
Conduct Good Storage and Good Distribution Practice (GSDP) inspections for premises used for the storage and distribution of pharmaceutical products.
Plan and prepare regulatory inspection of pharmaceutical establishments dealing with storage and distribution and ensure that all documentation and processes are following regulatory requirements.
Write inspection reports as per Rwanda FDA procedures.
Update and provide status of inspected pharmaceutical establishments.
Maintain a register of all inspected pharmaceutical establishments.
Prepare presentation of the inspection findings and present to the internal technical licensing committee.
Follow up with the pharmaceutical establishments on the corrective action and preventive actions (CAPAs) implementation
Maintain accurate records of inspection plan, concept notes and inspection reports, and regulatory filings related to good storage and good distribution practice (GSDP) inspections for pharmaceutical establishments.
Evaluate and assess safe disposal applications.
Supervise the safe disposal of unfit medical products and prepare certificate of safe disposal.
Provide training and guidance to employees on regulatory compliance and inspection requirements.
Conduct internal audits or assessments to evaluate the pharmaceutical establishment’s compliance with regulatory standards and suggest corrective actions when necessary.
Work closely across inspection teams and licensing teams, Rwanda FDA departments and External regulators to ensure inspection activities are planned and communicated effectively. and liaise with inspectors from international regulatory authority when needed.
Participate in the development of regulations, guidelines, manuals, standard operating procedures (SOPs) and other Quality Management System documents for the Rwanda FDA and stay up to date with changes in pharmaceutical regulations and guidelines as well as monitor regulatory updates and ensure that the pharmaceutical establishment adapt to any new requirements.
Ensure that processes, systems, and procedures needed for quality enhancement of the services offered by the Division are implemented.
Implement the approved strategic and business plans, including the achievement of performance targets.
Consistently provide quality services that meet customer and regulatory requirements within the Division in order to meet Rwanda FDA quality objectives.
Participate in organized training in Quality Management System and attend job-related trainings.
Participate and contribute to the Key Performance Indicators (KPI) program within the Division.
Effectively communicate objectives, goals and performance targets within the team and report regularly on progress against specified objectives, goals, and performance targets.
Promote a positive, open, friendly, and professional working environment.
Manage the associated risks and Audit queries through a clear governance process, ensuring that the correct procedure is followed, care taken, and ethical behavior demonstrated when managing inspection-related resources and that all relevant records and evidence is sufficiently maintained for Audit purpose.
Attend and contribute to meetings of the division as required.
Participate, as required, at national and international seminars, meetings in the areas of GSDP.
Respond to queries (technical and procedural) from internal and external customers.
Provide advisory support to key stakeholders, including participations in regulatory meetings and conferences external presentations all while demonstrating sound industry and technical knowledge.
Complete the assigned tasks by fully implementing the QMS established requirements.

Work Hours: 8

Experience in Months: 36

Level of Education: Bachelor Degree

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