QC Qualification Officer

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

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.

Your tasks

• 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.

You have

• 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.

Who are we looking for?

We are looking for a proactive and results-driven professional who takes ownership of responsibilities and is committed to continuous self-development. You work efficiently, collaborate effectively with colleagues and stakeholders, and have a strong focus on delivering high-quality results. As a tech-savvy professional, you quickly adapt to new technologies and systems and actively contribute to process improvements and operational excellence.

Our offer

• You will be part of a steadily growing and dynamic biopharmaceutical company offering a great environment for self-starters.
• A culture that is characterized by entrepreneurial spirit and a friendly and helpful atmosphere. The patient’s well-being is always our top priority. This combination is the basis for an interesting and challenging environment.
• You will be working in our dynamic headquarters in Leiden, where we work on the full project pipeline from development to commercial production.
• Being part of a company that is geared towards helping people live happier and healthier lives.
• A competitive salary that matches your responsibilities and experience.
• A 13th month salary
• 30 leave days.
• Company contribution to a pension package and health insurance.

Important notice to search firms and recruitment agencies

HAL Allergy does not accept unsolicited approaches from recruitment agencies and/or search firms (such as, for instance, the sending of resumes) for any job posted on this or a referring website. All recruitment agencies and search firms are required to contact HAL Allergy Recruitment via [e-mail] to enquire about a potential recruitment or search agreement with HAL Allergy.

HAL Allergy, for those who seek pharmaceutical innovation

HAL Allergy is one of the European top players in the development, production and distribution of allergen immunotherapies for the treatment and prevention of allergic diseases. We focus on the development and manufacturing of modified allergen extracts for the therapeutic and diagnostic purposes of respiratory and food allergies. With all our activities the patient's well-being is always top of mind. At Hall Allergy we foster open discussions, an entrepreneurial spirit and close collaborations within the teams and with our international colleagues summing up to more than 300 highly specialized people across various positions. If you too would like to become a part of an innovative and challenging pharmaceutical manufacturer, then this is your perfect opportunity!

HAL Allergy is headquartered in Leiden, where all disciplines work under one roof, from development to sales. We work in an informal, culturally diverse organization with room for growth and continued personal development. HAL Allergy is located in the middle of the thriving and energetic Leiden Bio Science Park, the largest innovation district of the Netherlands in the field of Life Sciences & Health. The central train station and the ancient city center of Leiden are just a 5 minute bike ride away from our office.