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Vacancy: Biologics Evaluation Trainer

Date 29 Jul 2019
Company USP Ghana
Location Accra
Job Type Contractor/Consultant
Industry NGO/IGO/INGO
Description


Job Description



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 Biologics Evaluation Course.



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




Required Skills or Experience




  • Applicant should demostrate ability and skills to teach above identified topics relating to Evaluation of Biologics of Pharmaceutical Products

  • Particular consideration will be given to current national regulators, pharmaceutical manufacturers, and international supply chain consultants





How To Apply




  • 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.    





Note



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