Summary
Date Posted: Monday, May 13 2024, Base Salary: Not Disclosed

JOB DETAILS:
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.

Work Hours: 8

Experience in Months: 36

Level of Education: Bachelor Degree

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