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Medicines Registration and Dossier Compilation Trainer

JOB SUMMARY

Company USP Ghana
Industry NGO/IGO/INGO
Category Medical/Pharm...
Location Accra
Job Status Contractor/Co...
Salary Very Attracti...
Education B.Pharm or M....
Experience 10 years
Job Expires Aug 28, 2019
Contact Erica Asante ...
 

Company Profile

The U.S. Pharmacopeial Convention (USP) USA is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP brings together more than 1,100 talented professionals across five global locations to deliver its mission to strengthen the supply of safe quality medicines and supplements worldwide. USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. Employment selection and related decisions are made without regard to sex, race, age, disability, religion, national origin, color, veteran status, sexual orientation, gender identity, or any other protected class. We are committed to working with and providing reasonable accommodation to individuals with disabilities. USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under a specific written agreement with USP

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 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

Required Skills or Experience

  • Applicant should demostrate ability and skills to teach above identified topics relating to Medicines Registrations and Dossier Compilation.
  • Particular consideration will be given to current national regulators, pharmaceutical manufacturers, and international supply chain consultants

How To Apply

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