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.
Job Description
Job Title: Medicines Registration And Dossier Compilation Trainer
USP Ghana provides courses featuring lectures from working professionals in key sectors. We are currently recruiting experts to teach Medicines Registration and Dossier Compilation.
The successful applicant should demonstrate the 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
- 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.