Brr Qof & Batch Disposition Quality Specialist Lazio

Brr Qof & Batch Disposition Quality Specialist
Roma
Lazio, Lazio

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. ) Responsibilities Perform the Batch of the commercial batches manufactured and prepare the release documents to be submitted for approval by the QP. Perform Statistical Control (AQL) activities downstream of the inspection for products manufactured in the DPS & PDS area. Train the personnel involved in quality activities. Support the investigation team in handling quality issues of batches manufactured for clinical and commercial use by identifying corrective and preventive actions. Collaborate on CAPAs management resulting from quality investigations, verifying their efficiency over time. Support and actively participate in initiatives/projects in the area of Operational Excellence. Actively join all meetings established for new and ongoing projects. Collaborate in coordinating technical and management meetings with customers. Support during clients/quality inspections (Audit) and internal and regulatory body quality inspections. Generate reports on quality events. Support the achievement of quality objectives for the part of the job competence, and of the RFT, Deviation Rate, Past due, Ontime closure objectives. Collaborate with Compliance colleagues in the Quality System SOPs review that fall within the scope of the Quality Unit. Provide support to customers via TLC and email, promptly responding to quality questions. Collaborate in the drafting of FMEAs. Draft, archive, and distribute controlled company documentation. Within the PDS organization, carry out document issuing activities to support Production/PPT/Quality System colleagues. Actively draft 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. Support the team and other functions in ensuring full support for Readiness and BUs processes. J-18808-Ljbffr