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This position is part of the Site Compliance Network Member (SCNM) team, which is the independent product-oriented quality team that has certain responsibilities concerning registration, validation and implementation within the site. Each SCNM is assigned one or more specific product(s) for which he/she is responsible.
The production processes and analytical methods of the drug products are described in the registration dossiers of the different markets. The SCNM is responsible to ensure regulatory CMC compliance of the practice of the site versus the content of the registration dossiers. This is achieved by participating in the following processes:
To this end, the SCNM has intensive consultations with partners within and outside the site. The external contacts with the Boards of Health of the markets mainly go through their GCMC (Global Chemistry, Manufacturing & Controls), with whom the SCNM maintains a close partnership. An important role of the SCNM is to form the bridge between the site and GCMC (~Boards of Health); on one hand the SCNM informs site colleagues on regulatory requirements, timelines, etc. and on the other hand the SCNM guards the interests of the site in external discussions.
The SCNM is the independent quality authority for product-related validations and in that way guards the quality of those validations and therefore the product quality. The validation domains in scope are:
The SCNM assist in coordinating the implementation of changes with regulatory impact in the site. To this end, he/she will follow up on the submissions and approvals in the different markets, and will provide this feedback to the site colleagues.
In addition, the SCNM is responsible for the content of the test plans (master data) in the LIMS system. This way, the SCNM ensures that the testing performed on the drug products is in compliance with the registration dossiers of the different markets.
Specific training and skills:
Project Engineer Pharma
Vast / Tijdelijk
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