Sr. QA Officer in Leiden // Fulltime

Quality Assurance

Netherlands, Leiden

Fulltime

V-

Competitive

Organization:

The Innovative Medicine division of a leading multinational pharmaceutical company has been a pioneer in biomedicines for over 25 years. Leveraging the advanced science of biotechnology, the company continually seeks new treatments for cancer, infectious diseases, cardiovascular and metabolic diseases, and immune-mediated inflammatory disorders (I.M.I.D.s). This division is part of a larger family of companies.

As Quality Assurance professionals, we are committed to consistently ensuring the delivery of safe, cost-effective, and high-quality products for patients in need. The QA department is divided into an Operational Commercial Products (OCP) branch and a New Product Development (NPD) & Launch branch. This position will be within the NPD group. QA provides comprehensive Quality support, including non-conformance management, CAPA, change control, validation, and batch disposition for clinical products/process validation batches, and supports advanced therapeutic developments at our site.

In addition to core business activities, the company has a significant project portfolio aimed at process improvement, new technology implementation, and capacity expansion to meet future demands. We are seeking a temporary contractor to support the base business and relevant projects, ensuring that changes are implemented in accordance with cGMP guidelines and quality management systems.

Activities and responsibilities:

The QA Officer acts as a quality expert and applies our Quality Systems to create, review and approve GMP documentation. The contractor works in close collaboration with other departments (Operations, QC, Planning, R&D etc.) The activities include, but are not limited to:

Paper and electronic batch record review

Raw material release

Document revisions review and approval

Review and approve analytical method transfer protocols and reports

Review and approve change controls, validation protocols and reports, validation assessments, and appliable lifecycle documentation depending on experience.

Track and monitor progress of changes to anticipate, flag and prevent any delays in change implementation.

Depending on experience supporting master material changes

Job requirements:

BSc/HBO (or equivalent) in bioscience, chemistry, pharmacy or equivalent;

One or more years of QA experience in pharmaceutical or related industry;

Up to date knowledge of current GMP regulations;

Experience in Change control and all documenting related activities;

Experience with documentation systems like Trackwise, True Vault is preferable;

Good communicative and advisory skills in English, both (verbal and written), understanding of Dutch;

Able to work independently as well as in a team.

If you want to discuss this opportunity, have questions or just want to express your enthousiasm: don’t hesitate to message!