Sr. QA Officer in Leiden
1 maand geleden
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
- 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
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