Our client is a global leader in healthcare and pharmaceutical products, with base in Leiden. Their mission is to transform individual lives and fundamentally change the way diseases are interpreted, managed and in the end prevented. In over 150 countries the company is bringing innovative science and together with the most creative minds in the industry think differently about diseases. Trying to achieve the best possible results for human health.
This department generates and manages several quality systems and is responsible for the release of products. They also provide advice on quality-related issues to the various products and production supporting departments and play an active role in several projects.
This department actively works together with other departments within the facility ensuring the quality of the products and quality systems. To ensure continuity they are looking for additional support in the QA department. The main focus involves Batch documentation review, review and approve incoming raw material requests and subsequent release. Other reviews and assessments are performed for but not limited to document changes, change control and validation-related documents.
- Review of raw material related documentation and release of raw materials
- Provide advice to requesting departments regarding GMP aspects
- Review and approve QA controlled documentation (SOP's, Batch Records and work instructions)
- Assessing change requests
- Review and Preparation of batch release documentation
- Support the department in continuous improvement activities
- Bachelor's degree in a relevant field
- Up to date knowledge of GMP regulations
- Preferably some years' of work experience in the (bio-)pharmaceutical industry
- Good knowledge of quality and documentation
- Able to work with and preferable have knowledge of automated systems
- Good communicative skills in Dutch and English
Within this role you will work in a multidisciplinary and dynamic team, looking for a candidate with excellent communication skills and can work independently and organized. Experience in change control would be a plus for this position.