Services and related deliverables are all associated with the company Integration Program as follows:
Provide Quality support to transition the European team over to the (US) eQMS within the required project lead times.
Specifically:
Ensure the eQMS meets the needs of the current EU requirements.Ensure procedures linked to the eQMS modules are compliant and/or implement local instructions.Ensure the changes are managed under local change control.
Provide Quality support to deliver an optimised vendor management system to achieve an integrated / harmonised approach (including but not limited to):
Qualification of vendorsMaintenance of vendors (auditing / vendor questionnaires etc.)Vendor performance monitoringDisqualification and off-boarding of vendors Provide general Quality support (to free Quality resource allocated to other integration activities).
Including but not limited to:
Performing vendor auditsUpdating procedures and Quality Technical AgreementsQuality rep for Deviations, Change Controls etc.Process improvement projects.
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