Job Opportunities at Rwanda Food And Drugs Authority (FDA)

1. Job Title: Retail and Wholesale Pharmacies Inspection Specialist 10 Positions

Job responsibilities

• 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, 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.

Minimum qualifications

• Bachelor's Degree in Biomedical Engineering, Microbiology, Pharmacy, Chemistry, Biology, Biotechnology, Pharmaceutical Sciences, Veterinary Medicine, Medical Sciences with 3 Years of relevant experience

• Master's Degree in Microbiology, Pharmacy, Chemistry, Biology, Biotechnology, Biomedical Engineering, Veterinary Medicine, Medical Sciences, Pharmaceutical Sciences with 1 Years of relevant experience

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2. Job Title: Veterinary Pharmacies Inspection Specialist 3 Positions

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.
• 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. 

Minimum qualifications

• Bachelor’s Degree in Animal Production, Pharmacy, Chemistry, Biotechnology, Pharmaceutical Sciences, Veterinary Medicine with 3 Years of relevant experience

• Master's Degree in Pharmacy, Chemistry, Biotechnology, Veterinary Medicine, Animal Production, Pharmaceutical Sciences with 1 Years of relevant experience

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3. Job Title: Good Clinical Practices (GCP) Specialist 2 Positions

Job responsibilities

• 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.

Minimum qualifications

• Bachelor's Degree in Public Health, Biomedical Engineering, Pharmacy, Biomedical Sciences, Medicine, Pharmaceutical Sciences, Molecular Biology, Biology, Biotechnology with 3 Years of relevant experience

• Master's Degree in Pharmacy, Biology, Biotechnology, Biomedical Engineering, Molecular Biology, Biomedical Sciences, Pharmaceutical Sciences with 1 Years of relevant experience

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4. Job Title: Biologicals and Blood Products GMP Specialist 2 Positions

Job responsibilities

• Understand and address unique considerations for the manufacturing of biologics, such as cell culture, fermentation, purification, and analytical testing.
• Assess and evaluate GMP inspections/ QMS Audit applications for manufacturing facilities of biologics and blood products in accordance with Rwanda FDA procedures.
• Conduct inspections and audits to ensure compliance with Good Manufacturing Practices (GMP) to produce Biologics and Blood products as accepted by Rwanda FDA.
• Monitor manufacturing processes to guarantee adherence to established quality standards.
• Evaluate and verify the entire manufacturing process, including upstream and downstream processes for biologics and blood products.
• Conduct risk assessments related to manufacturing processes to identify potential hazards and propose risk mitigation strategies.
• Write and compile detailed records of GMP inspections, inspection reports, deviations, corrective actions and contributing to the preparation of all other inspections.
• Assist in the compilation of data and preparation of management reports as required.
• Prepare and submit reports as required and appropriate records of meetings and activities.
• Update and maintain the databases and register of inspections performed, GMP compliant facilities and applications received for biologics and blood product manufacturers.
• Review GMP/QMS Audit dossiers prior to Division Manager’ s review.
• Stay updated on relevant regulations governing the production of biologics and blood products.
• Work closely across inspection teams, Rwanda FDA departments and/or other NMRAs to ensure inspection activities are planned and communicated effectively.
• Evaluate Standard Operating Procedures (SOPs) of Pharmaceutical Inspections and Licensing Division for compliance with GMP Guidelines as adopted by Rwanda FDA.
• Participate in the development of regulations, guidelines, manuals, standard operating procedures (SOPs) and other quality management system documents for the Division.
• Respond to queries (technical and procedural) from internal and external customers.
• Provide advisory support to key stakeholders, including participation in regulatory meetings and conferences external presentations all while demonstrating sound industry and technical knowledge.
• Liaise with inspectors from international regulatory authorities.
• Assist in internal and external audits to ensure that the biologics and blood product manufacturing facility complies with GMP regulations.
• Work with audit teams to address and rectify any findings related to GMP.

Minimum qualifications

• Bachelor's Degree in Biomedical Engineering, Microbiology, Pharmacy, Biology, Biotechnology, Pharmaceutical Sciences, Molecular Biology, Medicine, Biomedical Sciences with 3 Years of relevant experience

• Master's Degree in Microbiology, Pharmacy, Biology, Biomedical Engineering, Biotechnology, Molecular Biology, Biomedical Sciences, Pharmaceutical Sciences with 1 Years of relevant experience

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5. Job Title: GMP Inspection Specialist 2 Positions

Job responsibilities

• Assess and evaluate GMP inspections/ QMS Audit applications for manufacturing facilities of medical products in accordance with Rwanda FDA procedures as well as GMP inspection reports of other regulatory authorities on international pharmaceutical manufacturing sites where medical products for exportation to Rwandan are manufactured.
• Prepare and perform detailed inspections of pharmaceutical manufacturing facilities, processes, and documentation to ensure compliance with good manufacturing practices as per Rwanda FDA’s regulations.
• Write and compile inspection reports and to contribute to preparation of all other inspections reports.
• Communicate inspection findings, deviations, and recommendations to the relevant stakeholders, including management, quality teams, and regulatory bodies.
• Assist in the compilation of data, analysis and preparation of management reports as required.
• Prepare and submit reports as required and appropriate records of meetings and other related activities.
• Maintain and update the databases and registers of inspections performed, GMP compliant facilities and application received.
• Review GMP/QMS Audit dossiers and certificates or feedback letters (CAPA, etc.) prior to Division Manager’ s review.
• Perform risk assessments to identify potential areas of non-compliance and recommend risk mitigation strategies.
• Collaborate with teams to develop and implement corrective and preventive actions based on inspection findings.
• Work closely across inspection teams, Rwanda FDA departments and External regulators to ensure inspection activities are planned and communicated effectively.
• Evaluation Standard Operation Procedures (SOPs) of the division for compliance with GMP/ QMS Guidelines as adopted by Rwanda FDA.
• Provide training to manufacturing personnel on GMP regulations, standards, and best practices to enhance awareness and understanding.
• Identify opportunities for continuous improvement in GMP processes, qualify management systems, and manufacturing practices.
• Participate in the development of regulations, guidelines, manuals, standard operating procedures (SOPs) and other quality management system documents for the Division.
• Ensure that processes, systems and procedures needed for quality enhancement of the services offered by the Division are implemented.
• Implement approved strategic and business plans, including the achievement of performance targets.
• Consistently provide quality services that meet customer and regulatory requirements within Pharmaceutical Inspections and Licensing Division to meet Rwanda FDA quality objectives.
• Participate in organized training in Quality Management System.
• Ensure that inspection procedures remain up to date with relevant developments in National and International legislation, regulations, and guidelines.
• Contribute to the division’s compliance management process by ensuring that the instances of suspected or known non-compliance are handled in the appropriate manner.
• Prepare report for the division and relevant advisory and the Finance department.
• 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.
• Liaise with inspectors from international regulatory authority.

Minimum qualifications

• Bachelor's Degree in Biomedical Engineering, Microbiology, Biomedical Sciences, Pharmaceutical Sciences, Chemistry, Biotechnology, Pharmacy with 3 Years of relevant experience

• Master's Degree in Microbiology, Pharmacy, Chemistry, Biotechnology, Biomedical Engineering, Biomedical Sciences, Pharmaceutical Sciences with 1 Years of relevant experience

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6. Job Title: GEMP Inspection Specialist

Job responsibilities

• Develop comprehensive inspection plans, considering key engineering and manufacturing practices
• Execute inspections with precision, evaluating and identifying areas for improvement.
• Collect, analyze, and interpret data related to engineering controls, equivalent validation, and manufacturing processes.
• Identify trends, patterns, and deviations from GMP/GEP standards, providing detailed analysis.
• Conduct thorough reviews of documentation to ensure accuracy, completeness, and compliance with regulatory requirements.
• Verify the adequacy of records related to engineering practices and manufacturing processes.
• Provide guidance to ensure adherence to national and international standards.
• Collaborate with cross-functional teams to implement regulatory compliance measures.
• Lead or contribute to the development and implementation of corrective and preventive actions based on inspection findings.
• Monitor the effectiveness of CAPAs and provide guidance on continuous improvement.
• Prepare detailed and insight reports on inspection findings, highlighting areas of compliance and non-compliance.
• Conduct risk assessments related to engineering processes and equipment to identify and mitigate potential risks.
• Collaborate with team to establish risk mitigation strategies.
• Participate in the development of regulations, guidelines, manuals, standard operating procedures (SOPs) and other quality management system documents for the Division.
• Provide guidance to industry professionals on regulatory expectations related to good engineering and manufacturing practices.
• Work closely with experts in engineering, quality assurance, and other relevant fields to ensure a thorough and well-rounded inspection process.
• Collaborate with cross-functional teams to address complex engineering and manufacturing challenges.
• Identify opportunities for continuous improvement in inspection processes and methodologies.
• Stay informed about industry advancements and changes in regulatory requirements related to GMP/GEP.
• Develop and deliver training programs for industry professionals on best practices for GMP and GEP compliance. 

Minimum qualifications

• Bachelor's Degree in Biomedical Engineering, Electronical Engineering, Clinical Engineering with 3 Years of relevant experience

• Master's Degree in Electronics Engineering,Biomedical Engineering, Clinical Engineering with 1 Years of relevant experience

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