This organisation is a world-leader in the research & development and production of biotechnology and pharmaceutical products. Their main focus is the production of surgical lenses.
The CAPAs Specialist will pick up conformities and Corrective and preventive actions, to help the increasing production process.
• Documenting NC/CAPA in a GMP/FDA environment
• Working closely with dedicated Manufacturing engineers, Operators, QA engineers in the production process
• Documenting new events, initial risk assessment, product containment, root cause analyses, defining and driving Corrections, Corrective and Preventive actions
- BSc or MSc level of education
- A minimum of 3 years of relevant experience in QA, preferably in the medical devices industry
- Good communication skills in English and Dutch