GMP QC Systems Qualification Specialist

HAL Allergy Group; Leiden; On-site; EUR 45,000 - 70,000; Full time

Job summary

HAL Allergy is seeking a passionate QC Qualification Officer to join our Quality Control team in Leiden, the Netherlands. You will ensure that QC systems, laboratory equipment, and computerized systems remain qualified, validated, and compliant, enabling reliable testing activities.

You will manage the full lifecycle of QC equipment and systems, collaborating with internal stakeholders and external vendors to uphold GMP standards and regulatory compliance in a highly regulated pharmaceutical

Qualifications

• HBO-level lab/technical education required.
• Experience with GMP laboratory equipment.
• Knowledge of GMP guidelines and international regulations related to system management (validation, change control, deviation management).
• Good command of Dutch and English.

Responsibilities

• Coordinate all work related to QC systems and equipment.
• Monitor and maintain the qualified/validated status of QC systems and equipment.
• Organise and coordinate maintenance, calibration, and requalification with internal and external parties.
• Monitor equipment performance in collaboration with QC groups and propose improvements.
• Provide support in the event of equipment malfunctions.
• Organise, execute, and manage the implementation of new QC systems and equipment with system owners and users.
• Provide equipment-related documentation, such as operating instructions and logbooks.
• Ensure that maintenance-, calibration-, qualification-, and validation-related documentation is kept up to date.
• Coordinate and ensure that work performed by third parties meets contractual obligations and agreed quality and timelines.
• Write and follow SOPs, change controls (CCs), deviations (Devs), and CAPAs for QC systems.
• Perform troubleshooting for QC systems and equipment.
• Act as a Subject Matter Expert (SME) in projects and during audits.
• Provide training to equipment users.
• Educate and engage key users of systems and equipment to enable them to act as backups.
• Identify and report opportunities for optimisation and continuous improvement.
• Be prepared to undertake additional duties as required.

Skills

GMP guidelines

Project management

QC analytical equipment

IT knowledge

Dutch language

English language

Regulatory compliance

Education

HBO-level lab/technical education

Job description

HAL Allergy is seeking a passionate QC Qualification Officer to join our Quality Control team in Leiden, the Netherlands. You will ensure that QC systems, laboratory equipment, and computerized systems remain qualified, validated, and compliant, enabling reliable testing activities.

You will manage the full lifecycle of QC equipment and systems, collaborating with internal stakeholders and external vendors to uphold GMP standards and regulatory compliance in a highly regulated pharmaceutical