28 set - 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 GMP documentation. /ph3DIMENSIONS AND ASPECTS /h3pTechnical/Functional (Line) Expertise Required: Degree in scientific discipline and knowledge of pharmaceutical applicable regulations, or demonstrated/approved knowledge of manufacturing processes. Good command of English. Excellent knowledge of the manufacturing process and quality principles. Leadership Be positive Be accountable Be results-oriented Good communication skills Problem-solving attitude Good teamwork skills Good knowledge of cGMP Decision-making and Autonomy Good ability to work independently Interaction Good communication and negotiation skills Innovation Good ability to optimize workflows in classified areas Complexity Direct interface with Production, Maintenance, Calibration,
and Quality personnel /ph3EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS /h3pGood command of English (written and spoken) Excellent analytical and problem-solving skills Excellent communication, negotiation, and leadership skills Excellent technical writing skills and presentation skills. /ppLocations ITA - Rieti Base Salary Range: €31,200.00 - €42,900.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. /ppWorker Type Employee Worker Sub-Type Regular Time Type Tempo pieno /ppTakeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism - Integrity, Fairness, Honesty, and Perseverance - and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives - including your own. /ppTakeda is an equal opportunity employer. /p /p #J-18808-Ljbffr
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