QO Expert

h3Rôle Description /h3ulliVerifica la completezza e la corretta compilazione, secondo i requisiti di Assicurazione qualità dei Batch Record Reports generati dal Reparto di Produzione e provvede alla loro approvazione preliminare; /liliAssicura che i controlli sui Batch Record Reports vengano eseguiti in conformità alle procedure vigenti e nelle tempistiche previste; /liliValuta le deviazioni aperte dai reparti e verifica lo stato di eventuali deviazioni, in corso presso i reparti di produzione di prodotti APIs e prodotti finiti prima dell’approvazione dei lotti; /liliAssicura attraverso ispezioni periodiche interne che vengano rispettate le GMP nelle aree di produzione prodotti API e magazzini. /liliEffettua insieme al QO Lead Audit interni nei reparti e si occupa della preparazione dei report. /liliSi occupa di stampare i documenti necessari alla produzione; /liliSupporta il QO Lead nella gestione di batch note e deviazioni durante le attività di produzione. /li /ulh3Education /h3ulliDiploma di Scuola Media Superiore; /liliLaurea in Chimica, CTF, Scienze Biologiche /li /ulh3Experience /h3ulliConoscenza dei principi che regolano la gestione aziendale della Qualità. /liliConoscenza dei processi di produzione, dei flussi di laboratorio e dei servizi al Manufacturing. /liliConoscenza approfondita delle Norme di Buona Fabbricazione, delle procedure del Sito e della Compagnia /liliBuona conoscenza della lingua inglese. /li /ulh3CORE COMPETENCIES /h3ulliBuona Conoscenza delle GMP. /liliBuona capacità comunicativa. /liliCapacità di risolvere i problemi indipendentemente. /liliRispetto dei Zoetis Core Beliefs. /li /ulh3Role Description /h3ulliPerform review and assessment activities of manufacturing documentation to ensure compliance with applicable quality requirements and timely batch disposition and release. /li /ulh3KEY DUTIES AND RESPONSIBILITIES /h3ulliReview Batch Record Reports generated by the Manufacturing Department for completeness, accuracy, and compliance with Quality Assurance requirements, and perform preliminary approval. /liliEnsure Batch Record Report reviews are conducted in accordance with approved procedures and within established timelines. /liliAssess deviations initiated by operational departments and verify the status of any ongoing deviations within API and Finished Product manufacturing areas prior to batch approval. /liliConduct periodic internal inspections to verify compliance with current Good Manufacturing Practices (cGMP) in API manufacturing areas and warehouse operations. /liliParticipate with the Quality Oversight (QO) Lead in conducting internal audits of manufacturing departments and support the preparation of audit reports. /liliPrint and issue manufacturing documentation required to support production activities. /liliSupport the QO Lead in the management of batch records, investigations, and deviations during manufacturing operations. /li /ulh3QUALIFICATIONS /h3ulliHigh School Diploma required. /liliBachelor's Degree in Chemistry, Pharmaceutical Chemistry and Technology (CTF), Biological Sciences, or a related scientific discipline preferred. /li /ulh3EXPERIENCE /h3ulliKnowledge of Quality Management System (QMS) principles and quality governance processes. /liliUnderstanding of manufacturing processes, laboratory workflows, and manufacturing support services. /liliThorough knowledge of Good Manufacturing Practices (GMP), site procedures, and corporate quality standards. /liliGood command of written and spoken English. /li /ulh3CORE COMPETENCIES /h3ulliStrong knowledge of GMP regulations and compliance requirements. /liliEffective communication and interpersonal skills. /liliAbility to independently identify, analyze, and resolve problems. /liliCommitment to and demonstration of Zoetis Core Beliefs and values. /li /ulpFull time /ppAt Zoetis, our purpose is to nurture our world and humankind by advancing care for animals. As a Fortune 500 company and the world leader in animal health, we discover, develop, manufacture and commercialize vaccines, medicines, diagnostics and other technologies for companion animals and livestock. We know our people drive our success. Our award-winning culture, built around our Core Beliefs, focuses on our colleagues’ careers, connection and support. We offer competitive healthcare and retirement savings benefits, along with an array of benefits, policies and programs to support employee well-being in every sense, from health and financial wellness to family and lifestyle resources. /p #J-18808-Ljbffr