Participate in the preparation for regulatory inspections, providing direct support to system owners and main customers during inspections. * Together with BIM Teams, ensure direct follow-up of Compliance Audit activities, Deviations, Failure Investigations, Change Control, Qualification/Validation activities and associated documentation approval. * Ensure adequate quality reviews (periodic system quality reviews, quarterly utilities monitoring reports) * Using a Risk Based Approach, ensure that all Utilities, HVAC & Cleanroom Systems used Pharma & Injectable, T2, T4 and related supporting services are compliant with applicable regulations and guidelines (EMEA, FDA, PIC/S, ICH, best practices as defined by relevant organizations) and Corporate Policies & Procedures * Experience with Quality Management Systems and Auditing is an asset
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