QC Systems Qualification Lead – GMP Compliance & Validation

Qabird; Leiden; On-site; EUR 60,000 - 90,000; Full time

Benefits offered by this job

13th month salary

30 leave days

Company pension plan

Health insurance

Job summary

HAL Allergy is seeking a QC Qualification Officer to ensure QC systems and equipment stay qualified, validated and compliant for timely laboratory testing. You will coordinate lifecycle activities, calibrations, validation, and documentation, while driving improvements and ensuring GMP compliance.

Based in Leiden, you will collaborate with internal teams and external partners, write SOPs and CAPAs, and act as SME during audits and inspections to uphold quality standards.

Qualifications

• HBO-level laboratory-related or technical education.
• Experience with GMP laboratory equipment.
• Knowledge of GMP guidelines and international regulations related to system management, including validation, change control and deviation management.
• Strong IT and computer systems knowledge.
• Fluent in 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 the maintenance, calibration, and requalification of QC systems and equipment.
• Monitor equipment performance in collaboration with QC groups and propose improvements.
• Provide support in 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 documentation for maintenance, calibration, qualification, and validation is up to date.
• Coordinate work by third parties to meet contracts and quality timelines.
• Write, maintain, and follow up on SOPs, Change Controls, Deviations, and CAPAs.
• Perform troubleshooting for QC systems and equipment.
• Act as SME in projects and audits/inspections.
• Provide training to equipment users.
• Educate key users to enable backups.
• Identify opportunities for optimisation and continuous improvement.
• Be prepared to undertake additional duties as required.

Skills

GMP knowledge

Project management

Pharmaceutical QC equipment

IT/Computer systems

GMP guidelines & regulations

Dutch & English language

Education

HBO-level laboratory or technical education

Job description

HAL Allergy is seeking a QC Qualification Officer to ensure QC systems and equipment stay qualified, validated and compliant for timely laboratory testing. You will coordinate lifecycle activities, calibrations, validation, and documentation, while driving improvements and ensuring GMP compliance.

Based in Leiden, you will collaborate with internal teams and external partners, write SOPs and CAPAs, and act as SME during audits and inspections to uphold quality standards.