QO Expert

Rôle Description

• Verifica 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;
• Assicura che i controlli sui Batch Record Reports vengano eseguiti in conformità alle procedure vigenti e nelle tempistiche previste;
• Valuta 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;
• Assicura attraverso ispezioni periodiche interne che vengano rispettate le GMP nelle aree di produzione prodotti API e magazzini.
• Effettua insieme al QO Lead Audit interni nei reparti e si occupa della preparazione dei report.
• Si occupa di stampare i documenti necessari alla produzione;
• Supporta il QO Lead nella gestione di batch note e deviazioni durante le attività di produzione.

Education

• Diploma di Scuola Media Superiore;
• Laurea in Chimica, CTF, Scienze Biologiche

Experience

• Conoscenza dei principi che regolano la gestione aziendale della Qualità.
• Conoscenza dei processi di produzione, dei flussi di laboratorio e dei servizi al Manufacturing.
• Conoscenza approfondita delle Norme di Buona Fabbricazione, delle procedure del Sito e della Compagnia
• Buona conoscenza della lingua inglese.

CORE COMPETENCIES

• Buona Conoscenza delle GMP.
• Buona capacità comunicativa.
• Capacità di risolvere i problemi indipendentemente.
• Rispetto dei Zoetis Core Beliefs.

Role Description

• Perform review and assessment activities of manufacturing documentation to ensure compliance with applicable quality requirements and timely batch disposition and release.

KEY DUTIES AND RESPONSIBILITIES

• Review Batch Record Reports generated by the Manufacturing Department for completeness, accuracy, and compliance with Quality Assurance requirements, and perform preliminary approval.
• Ensure Batch Record Report reviews are conducted in accordance with approved procedures and within established timelines.
• Assess deviations initiated by operational departments and verify the status of any ongoing deviations within API and Finished Product manufacturing areas prior to batch approval.
• Conduct periodic internal inspections to verify compliance with current Good Manufacturing Practices (cGMP) in API manufacturing areas and warehouse operations.
• Participate with the Quality Oversight (QO) Lead in conducting internal audits of manufacturing departments and support the preparation of audit reports.
• Print and issue manufacturing documentation required to support production activities.
• Support the QO Lead in the management of batch records, investigations, and deviations during manufacturing operations.

QUALIFICATIONS

• High School Diploma required.
• Bachelor's Degree in Chemistry, Pharmaceutical Chemistry and Technology (CTF), Biological Sciences, or a related scientific discipline preferred.

EXPERIENCE

• Knowledge of Quality Management System (QMS) principles and quality governance processes.
• Understanding of manufacturing processes, laboratory workflows, and manufacturing support services.
• Thorough knowledge of Good Manufacturing Practices (GMP), site procedures, and corporate quality standards.
• Good command of written and spoken English.

CORE COMPETENCIES

• Strong knowledge of GMP regulations and compliance requirements.
• Effective communication and interpersonal skills.
• Ability to independently identify, analyze, and resolve problems.
• Commitment to and demonstration of Zoetis Core Beliefs and values.

Full time

At 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.