Quality officer

HAL Allergy; Leiden; On-site; EUR 55,000 - 75,000; Full time

Job summary

HAL Allergy in Leiden, the Netherlands, seeks a QC Qualification Officer to ensure that QC systems and equipment remain qualified, validated, and compliant, enabling timely and reliable laboratory testing. You will coordinate the full lifecycle of QC systems and equipment, including implementation, maintenance, calibration, qualification, validation, documentation, troubleshooting, and user training.

The role requires close collaboration with internal teams and external parties, acting as SME in

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 internal and external parties.
• Monitor equipment performance in collaboration with QC groups and propose improvements.

Job description

Omschrijving functie

QC Qualification Officer General information QC Qualification Officer The QC Qualification Officer ensures that QC systems and equipment remain qualified, validated, and compliant, enabling the timely and reliable execution of laboratory testing. The role is responsible for coordinating the full lifecycle of QC equipment and systems, including implementation, maintenance, calibration, qualification, validation, documentation, troubleshooting, user training, and continuous improvement, while ensuring compliance with GMP and regulatory requirements.

• 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...