15 ott - Rieti
ITA - 8290 Takeda Manufacturing Italia
ppJob Description 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. /ph3OBJECTIVES/PURPOSE /h3pVerifies 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. /ph3ACCOUNTABILITIES /h3ulliReview and ensure the execution of quality batch record review in compliance with SOPs and regulations. /liliOpen and manage events identified during batch record review and/or reported by production operators.
/liliReview production procedures and master batch record. /liliIdentify improvement opportunities and implement appropriate CAPA to increase GMP compliance in production areas. /liliActively collaborate with Production to identify and resolve compliance gaps, both documentation-related and on the shop floor. /liliLead/execute development projects aimed at deepening knowledge of production activities. /liliEnsure GMP documentation management, including archiving, data collection, and document destruction. /liliPrepare equipment cleaning samples. /liliVerify the compliance of plasma receipt requirements. /li /ulh3CORE ELEMENTS RELATED TO THIS ROLE /h3pWhat differentiates this role and represents its core elements is Quality Oversight: ensuring batch record review, data integrity of production systems, and the management of events, changes, and CAPAs; collaborating with Production to resolve compliance gaps and ensure traceability and control of G
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