Batch Release Compliance Auditor

Abbott; Pokeno; Sur place; NZD 65 000 - 86 000; Plein temps

Résumé du poste

Abbott in New Zealand is seeking a Batch Record Auditor to ensure batch records meet policies, procedures and regulatory requirements. You will maintain databases and ensure timely retrieval of historical data.

Based in Pokeno, Waikato, the role involves auditing batch records, coordinating corrective actions, generating reports and supporting product releases with strong attention to quality and compliance.

Qualifications

• Bachelor’s degree in a scientific or technical discipline or equivalent regulatory environment experience
• Strong judgment, problem-solving and decision-making skills
• Excellent written and verbal communication and interpersonal abilities
• Well-organized and tech-savvy with good regulatory knowledge

Responsabilités

• Maintain and continuously improve the batch release system to ensure compliance, product quality, and timely disposition of finished products.
• Conduct batch record audits to verify completeness, accuracy, and compliance with Abbott policies, procedures, deviation requirements, and applicable regulatory requirements.
• Follow up on all identified issues to ensure appropriate disposition information is obtained, enabling accurate and informed batch release decisions.
• Coordinate and document corrective action plans, sampling and verification activities, effectiveness reviews, and disposition assessments arising from quality and compliance events to support product release decisions.
• Ensure batch records, deviations, non-conformances, and other relevant compliance events are accurately documented and captured for reporting, trending, and performance metrics.
• Utilise batch release systems to manage material and batch status transactions, ensuring accurate product disposition and release status.
• Ensure affected materials and products are appropriately placed on hold or isolated when required, and verify that rework, sorting, disposal, or other disposition activities are completed, documented, and closed out in accordance with site procedures.
• Generate routine reports and retrieve data to support batch release activities, compliance monitoring, performance reporting, and business requirements.
• Perform routine compliance support activities, including document review, data collection, record verification, and administrative tasks to support product quality, compliance, and operational effectiveness.

Connaissances

Quality Assurance

Auditing

Regulatory knowledge

Analytical thinking

Communication

Organization

Tech-savvy

Formation

Bachelor’s degree in scientific or technical discipline

Description du poste

Abbott in New Zealand is seeking a Batch Record Auditor to ensure batch records meet policies, procedures and regulatory requirements. You will maintain databases and ensure timely retrieval of historical data.

Based in Pokeno, Waikato, the role involves auditing batch records, coordinating corrective actions, generating reports and supporting product releases with strong attention to quality and compliance.