This organisation is a world-leader in the research & development and production of biotechnology and pharmaceutical products. Their main focus is the production of biologic products and vaccines
As a Quality Engineer you will support the product and process development projects, as well as production, in the development of the quality policy and quality systems.
- Ensuring quality assurance within product and process development projects.
- Statistical analysis and implementation of statistical process control techniques, sampling schemes and others.
- Coordinating specifications for raw and auxiliary materials, processes, semi-finished and end products.
- (Co) guiding external (including DEKRA / FDA) and internal audits (CQA)
- Drawing up and reviewing protocols and reports.
- Non-conformity management, change control management.
- Continuous improvement of the focus area in response to regulatory developments, trends, deviations or other data-driven inputs.
- HBO education in an engineering discipline.
- 3+ years of experience in the pharmaceutical or medical device industry.
- Knowledge of GMP, MDD / MDR, QSR CFR 820, ISO 13485, ISO 14971.
- Knowledge of quality assurance systems
- Knowledge of validation of technical systems and processes.
- Knowledge of statistics and quality improvement techniques.
- Good communication skills in English and Dutch
- Availability to work in shifts (3 shifts)
For more information please contact Carla Garcia at firstname.lastname@example.org or +31 (0) 20 658 98 01.