GEMP Inspection Specialist at Rwanda Food And Drugs Authority (FDA) Under Statute : Deadline: May 20, 2024

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. 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.

Communicate inspection outcomes to relevant stakeholders, both within the regulatory agency and to the inspected facilities. Write and compile inspection reports when acting as lead inspector and contributing to preparation of all other inspections reports. 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 activities. Maintain and update the database and register of inspections performed, GMP compliant facilities and application received. Review GMP/QMS Audit dossiers prior to Division Manager’ s review. 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. 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. Provide guidance on implementing corrective and preventive actions to improve compliance. 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. Participate in the Key Performance Indicators (KPI) program within the Division Work with the Division manager to agree appropriate performance related targets. Take measures to identify and resolve issues impacting performance. Report regularly on progress against specified objectives, goals, and performance targets Effectively communicate objectives, goals, and performance targets within the team Assist in minuting the recommendations of relevant advisory committees of Pharmaceutical Inspections and Licensing Division applicable to the activities of the Division. Record statistics of generated and peer-reviewed reports. 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 Pharmaceutical Inspections and Licensing division as required. Liaise with relevant divisions of the Rwanda FDA to facilitate the identification, performance, Participate, as required, at national and international seminars in the areas of GEMP. Represent the Rwanda FDA as required, at national and international meetings and seminars on GMP topics. 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.

• • 1
    Bachelor’s Degree in Biomedical Engineering

    3 Years of relevant experience

• • 2
    Master’s Degree in Electronics Engineering

    1 Years of relevant experience

• • 3
    Master’s Degree in Biomedical Engineering

    1 Years of relevant experience

• • 4
    Bachelor’s Degree in Electronical Engineering

    3 Years of relevant experience

• • 5
    Master’s Degree in Clinical Engineering

    1 Years of relevant experience

• 6
  Bachelor’s Degree Clinical Engineering

  3 Years of relevant experience

Required competencies and key technical skills

• • 1
    Resource management skills

• • 2
    Problem solving skills

• • 3
    Decision making skills

• • 4
    Time management skills

• • 5
    Risk management skills

• • 6
    Results oriented

• • 7
    Digital literacy skills

• • 8
    Fluency in Kinyarwanda, English and/or French. Knowledge of all is an added advantage.

• 9
  Knowledge of data analysis

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