QO Expert

Zoetis; Sicilia; On-site; EUR 40,000 - 60,000; Full time

Job summary

Zoetis in Sicilia, Italy, is seeking a QA Reviewer to perform review and assessment of manufacturing documentation to ensure compliance with applicable quality requirements and timely batch disposition and release.

The role requires strong knowledge of GMP, QA processes, and English communication; you will participate in internal audits, support batch records management, and ensure adherence to site procedures.

Qualifications

• Knowledge of QMS principles and quality governance processes.
• Understanding of manufacturing processes and lab workflows.
• Good command of written and spoken English.

Responsibilities

• Review Batch Record Reports for completeness and compliance, and perform preliminary approval.
• Ensure that Batch Record Reviews follow approved procedures and timelines.
• Assess deviations and verify status of ongoing deviations in API and Finished Product areas before batch approval.
• Conduct periodic internal inspections to verify cgMP compliance in API manufacturing and warehouse operations.
• Participate with the Quality Oversight Lead in internal audits and support report preparation.
• Print and issue manufacturing documents required to support production activities.
• Support the QO Lead in managing batch records, investigations, and deviations during manufacturing.

Skills

GMP knowledge

Quality governance

Problem solving

Communication skills

Education

High School Diploma

Bachelor’s Degree in Chemistry/CTF/Biological Sciences

Job description

Rôle Description

Effettuare le attività di revisione e valutazione della documentazione di produzione dello stabilimento, assicurando il rispetto dei requisiti di conformità ed un adeguato tempo di rilascio dei lotti.

DUTIES AND RESPONSIBILITIES

• 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 EDUCATION

• 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

Regular

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