Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Responsibilities
* 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.
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