Job Description
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Previa verifica dei requisiti professionali, costituisce titolo preferenziale l’appartenenza alle Categorie Protette ai sensi dell’art 1 L. 68/99 e/o alle categorie di lavoratori che risultino percettori di interventi a sostegno del reddito e/o risultino disoccupati a seguito di procedure di licenziamento collettivo e/o lavoratori delle aziende del territorio di riferimento coinvolte da tavoli di crisi attivi presso il MIMIT.

_ OBJECTIVES/PURPOSE: _

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- Verifies and ensures compliance with GxP and site procedures, defining and maintaining collaboration between Quality and Production.
- Verifies and ensures product quality in accordance with regulatory requirements and standard operating procedures.
- Promotes and disseminates quality principles within the Production department.

_ ACCOUNTABILITIES: _

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- Review and ensure the execution of quality batch record review in compliance with SOPs and regulations.




- Open and manage events identified during batch record review and/or reported by production operators.
- Review production procedures and master batch record.
- Identify improvement opportunities and implement appropriate CAPA to increase GMP compliance in production areas.
- Actively collaborate with Production to identify and resolve compliance gaps, both documentation-related and on the shop floor.
- Lead/execute development projects aimed at deepening knowledge of production activities.
- Ensure GMP documentation management, including archiving, data collection, and document destruction.
- Prepare equipment cleaning samples.
- Verify the compliance of plasma receipt requirements.

_ CORE ELEMENTS RELATED TO THIS ROLE: _
What differentiates this role and represents its core elements isQuality Oversight:

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- ensuring batch record review, data integrity of production systems, and the management of events, changes, and CAPAs;
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📌 Quality Operations Coordinator (Gallicano Nel Lazio)
🏢 Takeda
📍 Gallicano Nel Lazio