Work Schedule Standard (Mon-Fri) Environmental Conditions Office - We perform the Batch of the commercial batches manufactured and prepare the release documents to be submitted for approval by the QP. - We perform Statistical Control (AQL) activities downstream of the inspection for products manufactured in the DPS & PDS area. - Trains the personnel involved in quality activities; - Supports the investigation team in handling quality issues of batches manufactured for clinical and commercial use, by identifying corrective and preventive actions; - We collaborate CAPAs management resulting from quality investigations, verifying their efficiency over time; - Supports and actively participates in initiatives/projects in the area of Operational Excellence; - Actively join all meetings established for new and ongoing projects; - We collaborate in coordinating technical and management meetings with customers; - Supports during clients/quality inspections (Audit) and internal and regulatory body quality inspections; - We generate reports on quality events; - We support the achievement of quality objectives for the part the job competence, and of the RFT, Deviation Rate, Past due, Ontime closure objectives; - We collaborate with Compliance colleagues in the r Quality System SOPs review that fall within the scope of the Quality Unit to which belongs; - Collaborates in the drafting of FMEAs; - Deals with the drafting, archiving, distribution of controlled company documentation; - Within the PDS organization, carries out document issuing activities to support Production/PPT/Quality System colleagues. - Actively drafts QATs and review them with Customers and site QPs. - Join initiatives in the PPI area (Kaizen and Gemba) supporting the continuous improvement of the site. - Supports the team and other functions in ensuring full support for Readiness and BUs processes.