For an international biotechnology company, we are looking for a Quality Officer. The Quality Officer 1 supports the department and site in publishing of metrics and reports and meeting coordination of projects. The QA Officer interacts directly with internal customers on change, CAPA and Deviation management, documentation and projects while being mentored by a senior QA Officer/ QA Project Manager. Capable of identifying and resolving Quality issues with assistance. The QA Officer will ensure superior customer service to internal customers. The company is in Geleen and offers a permanent position.
- Partner with internal customer as part of minor/non-complex change control, CAPA and Deviations.
- Issuance, verification, review of the Batch records, related deviations, CAPAs and CRF as well as OOS and EMP investigations.
- Review and approve SOPs, forms, and test methods within Document Management System. Responsibility is to ensure changes are justified; procedures are followed, and contain appropriate associated reference
- Review and approve non DMS documents (executed work orders, Engineering Preventative Maintenance documents, Environmental Action Reports)
- Manage and track Key Performance Indicator Quality metrics- represent department at site meetings (lot release, Deviation board, quality council when needed)
- Perform other duties as assigned.
- Knowledge of GMP’s and regulations
- Experience with Trackwise, SAP, Document Management System preferred
- Self-starter, excellent written and verbal communicator at all levels, able to tolerate challenging workloads and changing priorities, attention to detail, works effectively individually and with teams
- Live (near) in Geleen or willing to relocate.
ORGANISATION AND OFER
You will join growing and innovative organization and will be involved in successful projects with customers all over the world. You are part of a multi-disciplinary team that is continuously creating value for their clients.
This is a unique opportunity to develop yourself and to grow within the company. You can expect an attractive salary and benefits.
INTERESTED? Reach out to Sayf Idais for more information by contacting +31 (0)20 20 44 502 or firstname.lastname@example.org