QC Qualification Officer
General information
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 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.
- 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.
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.
- 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.

