Quality Systems Specialist

2 settimane fa

Florence, Italia Baxter A tempo pieno

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

SUMMARY

You will provide Quality Systems support to EMEA and Global Compounding organization to ensure that all sites maintain a compliant, efficient Quality Management System (QMS) in accordance with local regulatory requirements for Good Manufacturing Practice and Baxter Global QMS requirements.

You will manage and analyze Compounding quality systems data; reports into EMEA Compounding Quality System Sr Manager.

WHAT YOU'LL BE DOING

- Ensure the effective implementation of the Baxter Quality Management System in Compounding Facilities, in compliance with Global and local Regulatory requirements, by quality data monitoring and analysis (e.g. data collection & analysis of Quality KPIs/Metrics, for Global Compounding (GC) Management Reviews and PRO Site model)

- Quality System coordinator for EMEA & Global Compounding Quality documentation including:

Baxter Global Document Impact and Implementation process (QMSIS) SOP/ BGC and CECOM documents issuance on documentation management system TcU BAXU training course update and assignment GC SharePoint maintenance

- Coordination of Quality Notification to Management (QNTM) escalation process
Qualified Trainer for NCR/CAPA and Change Control processes.

- Other duties in support of Compounding Quality Systems as required, including support to Regional/Global Compounding

WHAT YOU'LL BRING:

Data analysis capability Excellent communication skills, include good level of English (written & spoken), Italian and/or French languages advantageous. Critical thinking, results-oriented, pragmatic Ability to operate remotely and within a matrix of colleagues, stakeholders, partners across different functions including site/regional Quality, Operations, Global Quality, Global Sterility Assurance, IT

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