Job responsibilities
To conduct dossier assessment for product registration To develop and adopt necessary regulatory tools such as guidelines, SOPs, and official forms within the regulatory framework to standardize and improve the assessment procedures, To contribute to the product register updates with variations, new registrations, and deletions due to GMP failure and safety issues, To assess bioequivalence of generic pharmaceutical products compared to reference products by reviewing bioequivalence studies, To organize samples for and liaise with the Division of Quality Control Laboratory testing and analysis to facilitate product assessment and registration. To participate and conduct operational research, programmes, and projects within the Division. To demonstrate the ability to consistently provide quality services that meet customer and regulatory requirements within his/her division to meet Rwanda FDA quality objectives. To participate in organized training in Quality Management System. To do the assigned tasks (job) by fully implementing the QMS established requirements
Minimum qualifications
-
-
1
Bachelor of Science in Pharmacy
3 Years of relevant experience
-
-
-
2
Master of Science in Pharmacy
1 Years of relevant experience
-
-
-
3
Bachelor’s Degree in Pharmacy
3 Years of relevant experience
-
-
-
4
Master’s Degree in Pharmacy
1 Years of relevant experience
-
-
-
5
Bachelor’s Degree in Pharmaceutical Sciences
3 Years of relevant experience
-
-
-
6
Bachelor’s Degree in Molecular Biology
3 Years of relevant experience
-
-
-
7
Master’s Degree in Molecular Biology
3 Years of relevant experience
-
-
8
Master’s Degree in Pharmaceutical Sciences
1 Years of relevant experience
Required competencies and key technical skills
-
-
1Resource management skills
-
-
-
2Analytical skills
-
-
-
3Problem solving skills
-
-
-
4Decision making skills
-
-
-
5Time management skills
-
-
-
6Risk management skills
-
-
-
7Results oriented
-
-
-
8Digital literacy skills
-
-
9Fluency in Kinyarwanda, English and/or French. Knowledge of all is an added advantage.
Click here to visit the website source