- 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;
- We provide support customers via TLC and email, promptly responding to quality questions;
- 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.