gmp consultant in naarden

toegevoegd
Dienstverband
interim
solliciteer nu

job details

toegevoegd
Standplaats
naarden, noord-holland
vakgebied
Overig
Dienstverband
interim
Referentie
IGB205968400
solliciteer nu

Vacature omschrijving


In this role you will manage the implementation of GMP Quality systems within a large pharmaceutical company.

Situation:

Our client currently has a wholesale distribution license to import products from within the EEA and to export to all markets globally.
There is a GDP (Good Distribution Practices) Quality system in place for the storage and distribution of medicinal products (which take place from a 3rd party warehouse and distribution center).
To enable the import of medicinal products from outside the EEA and to perform local repackaging/redressing a GMP Quality system needs to be implemented, in order to obtain a MIA (Marketing Importation Authorisation) license.

 Task description:

The GMP expert will manage and setup the necessary Quality systems according to GMP standards (EU Guidance and Sanofi Global policies), which will basically mean an upgrade from the existing GDP Quality Processes including:
-          Documentation (Site Masterfile)
-          Procedures (Change control/Self Inspection/ Deviations)
-          Training system (training curricula, training overview)
-          Operations (Procedures and Work Instructions related to repackaging/redressing, incl. batch release)
-          General inspection readiness according to Global Policies 

The GMP consultant will be reporting The Director Quality , supported 2 persons in NL, 1 in US and will work closely with the Supply Chain department.

Arbeidsvoorwaarden
This role can be filled both on a payroll basis or freelance, consecutively salary or rate is to be discussed
If you choose to be payrolled, we offer 25 vacation days, holiday pay, travel expenses (€0,19 per km).
Duration of project: 1 year with an option to extend

Vaardigheden

- At least a Bachelors Degree 
- At least 5 years of experience in similar or relevant projects
- Experience in implementing quality systems

Functie-eisen

HBO