QC Qualification Officer (m/f/d)

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

We are looking for a passionate and detail-oriented QC Qualification Officer to join our Quality Control team. In this role, you will ensure that QC systems, laboratory equipment, and computerized systems remain qualified, validated, and compliant, enabling reliable and timely laboratory testing activities.

You will manage the full lifecycle of QC equipment and systems, from implementation and qualification to maintenance, calibration, validation, troubleshooting, and continuous improvement. You will work closely with internal stakeholders, external vendors, and laboratory teams to ensure compliance with GMP requirements and industry regulations.

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 the maintenance, calibration, and requalification of QC systems and equipment with both internal and external parties.
• Monitor equipment performance in collaboration with QC groups and propose improvements where appropriate.
• Provide support in the event of equipment malfunctions.
• Organise, execute, and manage the implementation of new QC systems and equipment together with system owners and users.
• Provide equipment-related documentation, such as operating instructions and logbooks.
• Ensure that maintenance-, calibration-, qualification-, and validation-related documentation, including procedures, instructions, and equipment files, is kept up to date.
• Coordinate and ensure that work performed by third parties meets contractual obligations and agreed quality and timelines.
• Write, maintain, and follow up on SOPs, Change Controls (CCs),
• Deviations (Devs), and CAPAs related to the maintenance, calibration, qualification, and validation of QC systems and equipment.
• Perform troubleshooting for QC systems and equipment.
• Act as a Subject Matter Expert (SME) in projects and during internal and external audits and inspections.
• 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.

Requirements

• HBO-level laboratory-related or technical education.
• Relevant work experience with GMP laboratory equipment.
• Experience with project management is a plus.
• Knowledge of pharmaceutical QC analytical equipment.
• Knowledge of computer systems and information technology.
• Knowledge of GMP guidelines and relevant international regulations related to system management, including validation, change control, and deviation management.
• Good command of the Dutch and English languages.

About HAL Allergy

HAL Allergy is a leading international biotechnology company dedicated to improving the lives of people with allergies. Through the development, manufacturing, and distribution of allergen immunotherapy products, HAL Allergy helps patients achieve long-term relief and better quality of life. With a strong focus on innovation, quality, and patient safety, HAL operates in a highly regulated pharmaceutical environment and is committed to the highest GMP and compliance standards.