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  • Posted: Jul 30, 2019
    Deadline: Not specified
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    Since opening in 2013, USPGhana has trained more than 1000 professionals from 42 African countries on a range of pharmaceutical regulatory, quality assurance, and quality control functions. USPGhana works with partners to develop skills to deliver quality assured medicines to people who need them most.


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    Medicines Registration And Dossier Compilation Trainer

    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

     

    go to method of application »

    Medical Devices Course Trainer

    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

    Method of Application

        E-mail your resume, cover letter and salary/ Compensation history to [email protected].

        NOTE: All trainers are thoroughly vetted to avoid conflicts of interest and ensure compliance with USP’s Code of Ethics, as well as applicable laws and regulations. We also work closely with a potential trainer’s current employer to ensure conformance with applicable internal policies and procedures.

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