2 Job Positions of GMP Inspection Specialist Rwanda Food And Drugs Authority (FDA) Level:3.II Posts:2 Under Statute :Deadline May 20, 2024

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.

 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 GMP.  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
    Bachelor’s Degree in Microbiology

    3 Years of relevant experience

• • 3
    Master’s Degree in Microbiology

    1 Years of relevant experience

• • 4
    Bachelor’s Degree in Pharmacy

    3 Years of relevant experience

• • 5
    Master’s Degree in Pharmacy

    1 Years of relevant experience

• • 6
    Bachelor’s Degree in Chemistry

    3 Years of relevant experience

• • 7
    Bachelor’s Degree in Biotechnology

    3 Years of relevant experience

• • 8
    Master’s Degree in Chemistry

    1 Years of relevant experience

• • 9
    Master’s Degree in Biotechnology

    1 Years of relevant experience

• • 10
    Master’s Degree in Biomedical Engineering

    1 Years of relevant experience

• • 11
    Bachelor’s Degree in Pharmaceutical Sciences

    3 Years of relevant experience

• • 12
    Master’s degree in Biomedical Sciences

    1 Years of relevant experience

• • 13
    Master’s Degree in Pharmaceutical Sciences

    1 Years of relevant experience

• 14
  Bachelor’s Degree in Biomedical Sciences

  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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