Job responsibilities
Conduct Good Storage and Good Distribution Practice (GSDP) inspections for premises used for the storage and distribution of veterinary medicines. Plan and prepare regulatory inspection of establishments dealing with storage and distribution of veterinary medicines 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 veterinary pharmacies. Maintain a register of all inspected veterinary pharmacies. Prepare presentation of the inspection findings and present to the internal technical licensing committee. Follow up with the veterinary pharmacies 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).
Evaluate and assess safe disposal applications for veterinary medicines. Supervise the safe disposal of unfit veterinary medicines 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 veterinary pharmacy 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 regulations and guidelines as well as monitor regulatory updates and ensure that the veterinary pharmacies 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 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. Attend and contribute to meetings of the division as required. Participate, as required, at national and international seminars, meetings in the areas of inspections of veterinary pharmacies. 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. 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.
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1
Bachelor’s Degree in Animal Production
3 Years of relevant experience
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2
Bachelor’s Degree in Pharmacy
3 Years of relevant experience
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3
Master’s Degree in Pharmacy
1 Years of relevant experience
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4
Bachelor’s Degree in Chemistry
3 Years of relevant experience
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5
Bachelor’s Degree in Biotechnology
3 Years of relevant experience
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6
Master’s Degree in Chemistry
1 Years of relevant experience
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7
Master’s Degree in Biotechnology
1 Years of relevant experience
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8
Bachelor’s Degree in Pharmaceutical Sciences
3 Years of relevant experience
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9
Master’s Degree in Veterinary Medicine
1 Years of relevant experience
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10
Bachelor’s Degree in Veterinary Medicine
3 Years of relevant experience
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11
Master’s Degree in Animal Production
1 Years of relevant experience
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12
Master’s Degree in Pharmaceutical Sciences
1 Years of relevant experience
Required competencies and key technical skills
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1.Resource management skills
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2.Problem solving skills
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3.Decision making skills
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4.Time management skills
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5.Risk management skills
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6.Performance management skills
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7.Results oriented
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8.Digital literacy skills
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9.Fluency in Kinyarwanda, English and/or French. Knowledge of all is an added advantage.
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10.Data management systems skills
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