Work Schedule
Flex Shifts 40 hrs/wk
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
- 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;
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- 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.