Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob 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;
- 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.
Top Skills
What We Do
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
Why Work With Us
You will join a company which every colleague has the opportunity to create possibilities, for oneself, for our customers and patients. There is no more exciting place to be than at the forefront of solving problems which help improve lives around the world. As a company, we are committed to supporting your career aspirations and your journey.
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