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

 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.