2 Job Positions of Biologicals and Blood Products GMP Specialist at Rwanda Food And Drugs Authority (FDA) Under Statute : Deadline: May 20, 2024

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.  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 Division to meet Rwanda FDA quality objectives.  Participate in organized training in Quality Management System.  Foster a culture of GMP compliance and awareness within the organization.  Provide guidance and training to production and quality control teams on GMP requirements and best practices.

 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 reports for the division and relevant advisory and the Finance department.  Participate in the development and maintenance of the Key Performance Indicators (KPI) program and inspection metrics system for manufacturers of biologics and blood products 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

 Document the recommendations of relevant advisory committees of the 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 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 Biologics and Blood Products 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 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.

• • 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 Biology

    3 Years of relevant experience

• • 7

    Bachelor’s Degree in Biotechnology

    3 Years of relevant experience

• • 8

    Master’s Degree in Biology

    1 Years of relevant experience

• • 9

    Master’s Degree in Biomedical Engineering

    1 Years of relevant experience

• • 10

    Bachelor’s Degree in Pharmaceutical Sciences

    3 Years of relevant experience

• • 11

    Bachelor’s Degree in Molecular Biology

    3 Years of relevant experience

• • 12

    Master’s Degree in Biotechnology,

    1 Years of relevant experience

• • 13

    Master’s Degree in Molecular Biology

    1 Years of relevant experience

• • 14

    Bachelor’s Degree in Medicine

    3 Years of relevant experience

• • 15

    Master’s degree in Biomedical Sciences

    1 Years of relevant experience

• • 16. Master’s Degree in Pharmaceutical Sciences

    1 Years of relevant experience

• 17. 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.

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