Quality Operations Coordinator

15 ott - Gallicano Nel Lazio
Takeda

Job DescriptionVuole candidarsi? Legga tutte le informazioni su questa posizione qui sotto, poi prema il pulsante per candidarsi.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: _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: _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: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._ DIMENSIONS AND ASPECTS: _Technical/Functional (Line) ExpertiseRequired: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.LeadershipBe positiveBe accountableBe results-orientedGood communication skillsProblem-solving attitudeGood teamwork skillsGood knowledge of cGMPDecision-making and AutonomyGood ability to work independentlyInteractionGood communication and negotiation skillsInnovationGood ability to optimize workflows in classified areasComplexityDirect interface with Production, Maintenance, Calibration, and Quality personnel_ EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: _Good command of English (written and spoken)Excellent analytical and problem-solving skillsExcellent communication, negotiation, and leadership skillsExcellent technical writing skills and presentation skills_. xysqume _LocationsITA - RietiBase Salary Range:€31,200.00 - €42,900.00The 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.Worker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time#J-18808-Ljbffr

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