Quality Assurance Officer

Panda International; Geleen; On-site; EUR 42,000 - 64,000; Full time

Job summary

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.

Responsibilities

• 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.

Skills

GMP Knowledge

Label Control

Batch Record Review

Job description

QA Officer - Label Control & Batch Record Review

Location:

Geleen, Netherlands

Working model:

Floor-based, onsite role - exact onsite schedule to be confirmed

The Opportunity

We are looking for a hands-on QA Officer to support manufacturing operations at Lonza in Geleen. This is a shop-floor-focused Quality Assurance position with a strong emphasis on GMP label control, label reconciliation and operational batch record review.

You will work closely with Manufacturing, Warehouse and Quality Systems teams to ensure accurate documentation, maintain GMP compliance and support timely batch disposition.

Please note: This is a floor-based QA position requiring a strong operational presence. The contract duration and exact onsite schedule will be confirmed.

Key Responsibilities

• Manage the 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 operational and Aseptic Processing (AP/APS) batch record reviews to ensure accuracy, completeness and GMP compliance.
• Review and approve manufacturing documentation, including batch records, logbooks and supporting records.
• Identify, document and elevate documentation errors, deviations and GMP concerns.
• Support batch disposition through timely completion of QA documentation reviews.
• Provide shop-floor quality oversight and routine GMP monitoring.
• Collaborate with Manufacturing, Warehouse and Quality Systems teams to resolve documentation and compliance issues.
• Support inspections, audits and regulatory commitments relating to documentation and label control.
• Contribute to continuous improvement initiatives within manufacturing quality processes.

Focus of the Role

• 50-60%: GMP label issuance, reconciliation and label control.
• 30-40%: Operational and APS batch record review.
• 10-20%: Shop-floor QA support, investigations and continuous improvement.

Requirements

• Experience in Quality Assurance within a GMP-regulated pharmaceutical or biotechnology manufacturing environment.
• Knowledge of GMP documentation, label control and manufacturing quality processes.
• Experience reviewing batch records, logbooks and other controlled manufacturing documentation.
• Understanding of deviation reporting, discrepancy investigations and escalation processes.
• Strong attention to detail and the ability to identify documentation errors and compliance risks.
• Ability to collaborate effectively with Manufacturing, Warehouse and Quality teams.
• A proactive, hands-on approach to shop-floor quality support.

Experience with aseptic processing and APS documentation would be particularly relevant.

Interested?

If you have hands-on GMP QA experience and enjoy working closely with manufacturing teams, we would be happy to discuss this opportunity with you.