I’m working exclusively with my fast growing & innovative pharmaceutical client based in the Randstad. This Scale up is using their patented knowledge of drug formulation, they have developed active pharmaceutical ingredients for clinical investigations and perform clinical trials. The reason for the role being open is because they are extending rapidly and in need of extra support.
They are in need of a Quality Assurance Officer on Temporary to Permanent construction. This is an exciting opportunity to become part of a fast-paced team of professionals, and to set develop yours skills within a GMP environment.
Start Date: ASAP / Duration: 6 Months minimum / Hours: 32 - 40 per week
Role:
Quality management system;
- Further development, improvement and maintenance of the GMP and GDP quality system and other relevant qualities applicable
- Perform and report internal audits
- Reporting on quality indicators to the management, prepare and implement improvements
- Improvement of the QMS which includes writing new procedures, enhancement of existing procedures, update and maintenance of databases
- Give training and advice in the field of GMP and GDP to colleagues
Review and batch release;
- review and approve document changes as well as review and approve new and revised QA-documents
- Review and approve of change forms, deviation reports, complaints, and CAPA's. Overview of the progress and completion of change forms, deviations and CAPA's
- Review and improvement of validation protocols and reports. Preperation of validation assessment upon purchase of new equipment/systems and upon proposed changes
- Review of batch documentation and QC results
Skills:
- Juinor / Medior experience in the Pharmaceutical, Medical Device and/or Biotechnology sector
- Knowledge of GMP and GDP Quality Systems
- Knowledge of pharmaceutical production process
- Experience as QA officer / document controller in pharmacheutical industry
Interview process: 2 stage interview process via Teams or (preferably) Face to Face