Our client is a multinational pharmaceutical company that has been for more than 25 years a leader in biomedicine market. They we continue to seek innovative ways to treat different types of illness.
This is an opportunity to work with a highly motivated team and to be part of a global market leader.
The company is located in Leiden, Netherlands.
The department of Operations is responsible for the execution of the process and making of the product. This role controls that quality systems are applied as per GMP standards
Responsibilities. The Quality department has an important role in providing advice on quality topics to all departments of the supply chain.
- Lead all aspects of site investigations and ensure that all steps are implemented and effective within agreed timelines.
- Setup and coordinate Site and Global critical issue meetings.
- Perform level assessment, review, and approval of (deviation-related) change controls.
- Review and approve study protocols and reports to assure that studies will be executed in a controlled manner following GMP and regulatory requirements.
- Bachelor or Master degree in science subject and /or business-related.
- Minimum 4 years of experience.
- GMP knowledge.
- English advance (written and oral).
- CAPAS knowledge
- Experienced in working with TrackWise (software)