Based in Bilthoven, you will maintain the quality system and documentation, review batch records and release documents, support partner qualifications, and contribute to audits and continuous improvement.
The role
As a Quality Assurance Officer at our client company in Bilthoven, you will manage and maintain the quality system and its documentation, helping ensure product quality and compliance.
You will mainly work as part of a QA team of around six colleagues, and independently when needed. You report to the Quality Manager and, functionally, to plant management.
Responsibilities
- Review batch records and assess release documentation.
- Take part in qualification activities for external partners and support the Drug Substance and Drug Product teams with supplier and contract qualifications.
- Draft general and specific SOPs, maintain existing procedures, and advise other departments on quality matters.
- Organize and conduct audits and self-inspections, and contribute to continuous improvement and training.
Additional information
Specific education or experience requirements, the work schedule, hours, contract type and salary are not stated in the available information.