Quality Support Engineer QA – QS&E
For one of my leading Biopharmaceutical clients in Geel, Belgium I am looking for a Quality Support Engineer. You will be working on quality GMP compliance projects concerning Qualification of (process) equipment, utilities and facilities & automation systems.
- Change Controls for equipment, utilities & facilities, automation systems.
- Deviation/complaints Management
- Ensure quality oversight of the operational and project activities by documented QA approval of GMP documentation, periodic system quality reviews and by active participation in project teams including:
- Review and approval of Qualification Documents (URS/SRS, Impact Assessments, PQP, DQ IQ OQ & PQ protocols & reports, QSR
- Review and approval of cleaning test/monitoring/verification & validation protocols and reports, Change Controls
- Review and approval of SAP Master Data, periodic monitoring and Periodic System Quality Review documents (PSQR)
- Support in-depth investigations by providing technical, quality and compliance expertise
- Define adequate CAPA’s for Quality Investigations regarding equipment, utilities and facilities, automation and cleaning with potential quality impact
- Master’s Degree in scientific/technical discipline preferred
- 2-4 years of working experience
- Understanding of pharmaceutical product development, qualification, validation, manufacturing, packaging, labelling, testing, release, storage and distribution processes
- Knowledge of task related cGMP regulations and guidelines
- Technical background and base knowledge of chemical/pharmaceutical process equipment
- Strong analytical thinking, risk assessment and decision-making skills
- Dutch and English (spoken as well as written)
Duration: until 30-06-2023, high chance of extension
Start: ASAP (flexible)
Hours p/w: Fulltime on-site in Geel
Get in touch ASAP by sending your CV to firstname.lastname@example.org or call me on +31202044502! You can also refer a friend and both earn a bonus on placement.