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[e-drug] QUAMED is looking for regulatory expertise

E-DRUG: QUAMED is looking for regulatory expertise

Dear E-druggers,

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
  *   Pharmacovigilance
  *   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. A good knowledge of 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 
info@quamed.org and we will be in touch.

Looking forward to your email!

Ed Vreeke, Executive Director, QUAMED.

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