GMP QA Officer: Label Control & Batch Records

Panda International; Geleen; Sur place; EUR 42 000 - 64 000; Plein temps

Résumé du poste

Lonza in Geleen, Netherlands seeks a hands-on QA Officer focused on GMP label control, label reconciliation and operational batch record review on the shop floor. You will collaborate with Manufacturing, Warehouse and Quality Systems to ensure accurate documentation and GMP compliance, supporting timely batch disposition.

The role emphasizes floor-based quality oversight with 50-60% label control, 30-40% batch record review and 10-20% on-site QA support, investigations and improvement

Qualifications

• Experience in QA within GMP-regulated pharmaceutical/manufacturing environments.
• Knowledge of GMP documentation, label control and manufacturing quality processes.
• Experience reviewing batch records and controlled manufacturing documentation.
• Understanding of deviation reporting, discrepancy investigations and escalation processes.
• Proactive, hands-on approach to shop-floor quality support.

Responsabilités

• Manage issuance, control, reconciliation and accountability of GMP labels.
• Verify label requests against approved documentation and production schedules.
• Review completed label issuance records and investigate discrepancies.
• Conduct batch record reviews for AP/APS to ensure GMP compliance and accuracy.
• Review and approve manufacturing documentation, including batch records and logbooks.
• Identify, document and elevate documentation errors and GMP concerns.
• Support batch disposition through QA documentation reviews.
• Provide shop-floor QA oversight and GMP monitoring.
• Collaborate with Manufacturing, Warehouse and Quality Systems to resolve issues.
• Support inspections, audits and regulatory commitments related to documentation and label control.
• Contribute to continuous improvement of manufacturing quality processes.

Connaissances

GMP Knowledge

Label Control

Batch Record Review

Description du poste

Lonza in Geleen, Netherlands seeks a hands-on QA Officer focused on GMP label control, label reconciliation and operational batch record review on the shop floor. You will collaborate with Manufacturing, Warehouse and Quality Systems to ensure accurate documentation and GMP compliance, supporting timely batch disposition.

The role emphasizes floor-based quality oversight with 50-60% label control, 30-40% batch record review and 10-20% on-site QA support, investigations and improvement