Jefferson Wells * Wavre * Vast contract, onbepaalde tijd * Voltijds - Solliciteer als één van de eersten - Contracting – Brabant Wallon - Vos responsabilités - The QA Ops Aseptic Processes Senior Specialist is responsible for developing, implementing, and overseeing the sterility assurance practices to maintain compliance with regulatory requirements and industry standards. * Manage critical and complex major deviations linked to Sterility Assurance (e.g. hidden surface, gradeA/B contaminations etc.) and manage CAPA's in respect to the compliance and the product quality. * Approve Environmental Monitoring Risk Assessment, * Is the SME for the Sterility Assurance topics in manufacturing units, approve the SOP's related to the subjects, support the Sterility assurance Ops specialists. * Approve AQ and aseptic audits (9000002094), coaching during APS is required periodic
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