ph3Job Description: /h3 pPrevia 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. /p h3OBJECTIVES/PURPOSE : /h3 ul liVerifies and ensures compliance with GxP and site procedures, defining and maintaining collaboration between Quality and Production. /li liVerifies and ensures product quality in accordance with regulatory requirements and standard operating procedures. /li liPromotes and disseminates quality principles within the Production department. /li /ul h3ACCOUNTABILITIES : /h3 ul liReview and ensure the execution of quality batch record review in compliance with SOPs and regulations. /li liOpen and manage events identified during batch record review and/or reported by production operators. /li liReview production procedures and master batch record. /li liIdentify improvement opportunities and implement appropriate CAPA to increase GMP compliance in production areas. /li liActively collaborate with Production to identify and resolve compliance gaps, both documentation-related and on the shop floor. /li liLead/execute development projects aimed at deepening knowledge of production activities. /li liEnsure GMP documentation management, including archiving, data collection, and document destruction. /li liPrepare equipment cleaning samples. /li liVerify the compliance of plasma receipt requirements. /li /ul h3CORE ELEMENTS RELATED TO THIS ROLE : /h3 pWhat differentiates this role and represents its core elements is Quality Oversight /p ul liensuring batch record review, data integrity of production systems, and the management of events, changes,



and CAPAs; /li licollaborating with Production to resolve compliance gaps and ensure traceability and control of GMP documentation. /li /ul h3DIMENSIONS AND ASPECTS : /h3 h3Technical/Functional (Line) Expertise : /h3 h3Required : /h3 ul liDegree in scientific discipline and knowledge of pharmaceutical applicable regulations, or demonstrated/approved knowledge of manufacturing processes. /li liGood command of English. /li liExcellent knowledge of the manufacturing process and quality principles. /li /ul h3Leadership : /h3 ul liBe positive /li liBe accountable /li liBe results-oriented /li liGood communication skills /li liProblem-solving attitude /li liGood teamwork skills /li liGood knowledge of cGMP /li /ul h3Decision-making and Autonomy : /h3 ul liGood ability to work independently /li /ul h3Interaction : /h3 ul liGood communication and negotiation skills /li /ul h3Innovation : /h3 ul liGood ability to optimize workflows in classified areas /li /ul h3Complexity : /h3 ul liDirect interface with Production, Maintenance, Calibration, and Quality personnel /li /ul h3EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS : /h3 ul liGood command of English (written and spoken) /li liExcellent analytical and problem-solving skills /li liExcellent communication, negotiation, and leadership skills /li liExcellent technical writing skills and presentation skills. /li /ul h3Locations : /h3 pITA - Rieti /p h3Base Salary Range : /h3 p€31,200.00 - €42,900.00 /p pThe 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. /p h3Worker Type : /h3 pEmployee /p h3Worker Sub-Type : /h3 pRegular /p h3Time Type : /h3 pFull time /p /p #J-18808-Ljbffr

📌 Quality Operations Coordinator (Rieti)
🏢 Takeda
📍 Rieti