DUTIES AND RESPONSIBILITIES 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
📌 QO Expert (Sicilia)
🏢 Zoetis
📍 Sicilia
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