Quality Assurance Engineer | Pharmaceutical
My client is an international pharmaceutical company located in the North of the Netherlands. Their focus is on finding, developing, and producing a cure for various infectious diseases to help the sick affected by it.
In this role, you will be part of the Quality Assurance Department. Offering support with product and process development as well as improvement from the quality system will be part of your main tasks in this position.
- Ensuring quality assurance within product and process development projects
- Conducting and assessing statistical analyzes and supporting the implementation of statistical process control techniques, sampling schemes, and other quality techniques
- Assessing and (co-) determining specifications for raw and auxiliary materials, processes, semi-finished and finished products in relation to internal and external quality standards
- (Co) guiding external (including DEKRA / FDA) and internal audits (CQA)
- Drawing up and reviewing protocols and reports
- Non-conformity management
- Advising, reviewing, and (approving) changes to products/processes or systems, in line with the applicable procedures. Approve all QMS related procedures and work instructions
- Provide input to the Site Management Review
- Continuous improvement of the focus area in response to regulatory developments, trends, deviations or other data-driven inputs.
- Some years of experience within the pharmaceutical or medical devices industry
- Bachelor degree in the technology direction
- Knowledge of GMP is a must
- Knowledge of QSR CFR 820, ISO 13485, ISO 14971
- Experience working with QMS
- Experience working with validation of technical systems and processes
- Excellent communication in English and Dutch
- Currently living in The Netherlands or a valid EU working permit