QUAMED (www.quamed.org) is a not-for-profit organisation specialising in various aspects of pharmaceutical quality assurance. We conduct pharmaceutical assessments and audits, we develop and facilitate training courses around pharmaceutical quality, auditing and inspection and we organise and provide technical assistance in the field of pharmaceutical quality assurance.
We have started two projects that have as objective to support national regulatory authorities to obtain WHO Global Benchmarking Tool maturity level 3 or 4 (for medicines and vaccines: GBT+). To assist us in those projects, we are looking for people that have significant experience working with or for regulatory authorities. We are looking for seasoned experts that are interested in contributing to improving a regulatory system in a sustainable manner.
We are looking at filling both long-term assignments with placement in-country (up to two years) and looking at short-term assignments with regular in-country visits and remote support.
The assignments will include, on-the-job training and mentoring, training facilitation, document and standard development, joint audits and inspections and many other elements that will contribute to improving the systems, processes and operations of the regulatory authorities.
We are looking for #consultants speaking English and/or French with strong expertise in:
- Product dossier evaluations, Registration & Market authorisation (including vaccines)
- Regulatory licensing and Good Manufacturing Practices Inspections (including vaccines)
- Legal framework and regulatory support
- Clinical trial oversight
- Vaccine lot release
- General Quality Management System support
Expertise with Stringent Regulatory Authorities or WHO Listed Authorities of maturity level 3 or 4 would be highly appreciated. Good knowledge of the WHO Global Benchmarking Tool will also be an asset.
If you fit the profile and you would like to know more about the possibilities, please do not hesitate to send an email with your CV and your availability to firstname.lastname@example.org and we will be in touch.
Looking forward to your email!