Job Vacancies at USP-Ghana

Help us improve Public Health in Africa.

Falsified and substandard medicines threaten recent improvements to global public health–particularly in  Africa. USP and its collaborators work across the region to ensure quality medicines availability. Join us in helping our partners develop skills needed to deliver quality assured medicines to citizens who need them most.

USP Ghana provides courses featuring lectures from working professionals in key sectors.  We are currently recruiting experts to teach Medicines Registration and Dossier Compilation.

Successful applicant should demostrate ability to teach below topics of interest and examine training candidates.

•     Dossier Evaluation Introduction
•     Introduction to the New Registration Guideline in CTD format
•     Active Pharmaceutical Ingredients (API): General Information
•     Stability of API
•     Pharmaceutical Product Development
•     Manufacturing: Finished Pharmaceutical Product (FPP)
•     Finished Pharmaceutical Product Specification
•     Process Validation and Annual Report
•     Analytical Method and Validation
•     Stability Data Assessment of FPP
•     Introduction to Bioequivalence and Requirements
•     Interchangeability and Bioequivalence
•     BCS Based Biowaivers
•     API Specification Assessment
•     FPP Dossier Assessment in CTD
•     FPP Common Deficiency and Tips
•     Sterile Product: Introduction

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Help us improve Public Health in Africa.

Falsified and substandard medicines threaten recent improvements to global public health–particularly in  Africa. USP and its collaborators work across the region to ensure quality medicines availability. Join us in helping our partners develop skills needed to deliver quality assured medicines to citizens who need them most.

USP Ghana provides courses featuring lectures from working professionals in key sectors. We are currently recruiting experts to teach Medical Devices Course.

Successful applicant should demostrate ability to teach below topics of interest and examine training candidates;

    Landscape of regulation of IVD Medical Devices (Global approaches)

•         IMDRF (GHTF)/Harmonization
•         AHWP
•         PAHWP
•         ALLADIV
•         WHO

    Definition of a medical device and regulating medical devices

•         Law
•         Regulations/Guidelines
•         Regulatory Authority/ Role
•         Key stakeholders (Government and Non-Government Institutions)
•         Elements and mechanisms for regulatory oversight
•         Pre market controls
•         Post market controls

    Key principles in establishing medical devices safety and performance

•         Risk classification (Classification Rules)
•         ISO Standards
•         Global Medical Device Nomenclature (GMDN)
•         UDI
•         QMS (ISO 13485)
•         Clinical Performance Studies
•         Post Marketing surveillance

    Introduction to GHTF Guidelines for assessment of Technical files

•         Content of Medical Devices Technical Documentation
•         Medical devices exempted from registration (listing)
•          Fees
•         Abridged /Full assessment of Technical files (Dossier)
•         CSDT (Common Submission Dossier Template) GHTF
•         STED (Summary Technical Documentation)
•         Renewal, alterations
•         Labelling requirements

    Review of Information Provided to a Regulatory Authority

•         Assessment of documentation submitted for marketing authorization purposes