The company has a Biotech and Pharmaceutical operations site. They are one of the biggest innovative companies in the Netherlands and they are specialized in vaccines, biological therapies and medicines.
- The Quality Auditor conducts routine audits of data, information, procedures, equipment and systems (including computer systems), and/or facilities to ensure the compliance with SOP and GMP and worldwide regulations
- Review and approve production and analytical documentation accompanying the release of API, Safety Assessment or clinical supply lots (bulk and packaged) to ensure conformance to appropriate regulatory requirements.
- Communicates and resolves audit comments with client areas.
- Experience should be in the pharmaceutical/chemical industry or government drug-regulatory agency with a working knowledge of cGMP regulations.
- Effective communications (oral/written) and interpersonal skills are necessary