Expression of Interest For Individual Consultant Services For Preparation, Establishment, And Training In Good Manufacturing Practices (Gmp) And Product Registration

Expression of Interest for Individual Consultant Services for Preparation, Establishment, And Training in Good Manufacturing Practices (Gmp) and Product Registration 02. Scope of the assignment /responsibilities of the consultant. Outline processes and steps to follow while conducting a systematic assessment of the organization to determine whether the manufacturer comply with quality system and current Good Manufacturing Practices (cGMP) to ensure regulatory compliance and certification readiness. Dossier Compilation, Compile registration documents as per regulatory standards for products manufactured by AgroPy Ltd for submission at Rwanda FDA and other Regulatory bodies where AgroPy Ltd would want to market their products. Assess existing dossier information in terms of compliance with legislative requirements identifying gaps necessitating updating before submission, that assist in overcoming irrelevant queries as to reduce long periods of registration. List all required documentation required by a manufacturing to comply with regulatory requirements. Develop missing required documentation for all manufacturing processes. Review the existing documents to identify the missing content and align to regulatory requirements. Conduct training on GMP requirements and on the developed documents for AgroPy Ltd staff to increase their knowledge and understanding for regulatory compliance. 03. Duration of the consultancy This assignment will be for 12 months to take place from the date of the contract signing. 04. Duty station. Consultant to work both remotely and on site. Travel to the venue (Musanze) for days that require onsite activities. Deliverables may be submitted electronically. Closing the non-conformities from the inspections and accampagning the AgroPy Ltd up to GMP certification. 05. Deliverables The consultant will be expected to provide the following deliverables electronically: a) Inception report outlining the process for the asignment that demonstrates how the consultant will deliver on the scope of work b) Systematic assessment report of the organization to identify the gaps related to regulatory compliance and certification readiness C) Reviewed dossiers with comments for product registration as per regulatory standards for products manufactured by AgroPy Ltd for submission at Rwanda FDA and other Regulatory bodies where AgroPy Ltd would want to market their products for D) Developed/reviewed documents required by AgroPy Ltd to comply with regulatory requirements. E) GMP training report for AgroPy Ltd staff to increase their knowledge and understanding for regulatory compliance. F) CAPA report responding to Rwanda FDA existing queries. 06. Monitoring and progress control, including reporting requirements, periodicity format and deadline: The consultant is required to seek inputs and provide periodic updates to the designated person by AgroPy Ltd. The consultant will be required to participate in meetings required to finalise the assignment. 07. Supervisory arrangements: The consultant will contractually work under the supervision of the general supervision of AgroPy Ltd. 08. Qualifications, expirience and skills: Interested Individuals must meet the following requirements: a) Graduate level education (masters or higher) in regulatory sciences. b) At least ten years of experience of working at a National Regulatory body as GMP inspector and dossier assessment for product registration. c) Previous experience in developing site master file, quality manuals, policies, protocols, SOPs, forms and formats used in manufacturing processes (Related to GMP) d) Fluency in English (written and spoken), (French will be an added advantage) 09. Proposal submission guidelines The proposal should demonstrate sound knowledge, technical skills and capability as required by the nature of the work assignment and understanding of the requisite tasks set forth in the scope of the assignment Applicants should submit both technical and financial proposals. The financial proposal should quote consultancy fees. The technical proposal should have the following sections: Understanding of the assignment methodology to be used in undertaking the assignment performance monitoring and reporting work plan / activity schedule Location: Musanze Deadline: Friday, 12/06/2026 17:00 Tender Link : https://www.jobinrwanda.com/job/request-expression-interest-individual-consultant-services-preparation-establishment-and