17 ott - Sicilia
Zoetis
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 independen
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