Sr QA-Officer/Qualified Person
You will work as Sr QA-Officer at the QA department of Eurofins Proxy with 12 QA colleagues and will follow a training program to be certified as Qualified Person.
- You maintain a GMP compliant Quality Management System for manufacturing and quality control of biological drug substances and related final products based on applicable regulations and guidelines.
- You investigate customer complaints and act as point of contact towards customers for Quality related matters.
- You host and support customer audits and regulatory inspections
- You support and coordinate risk assessments.
- You support and review the qualification of production equipment, test equipment and cleanroom facility.
- You will review and approve batch records.
- You will release batches of biological intermediate products, drug substances and related final products (Investigational Medicinal Products).
As a Qualified Person you like to work in a dynamic environment and your heart beats faster for a great diversity of products. Your excellent communication skills and your strong personality make it easy to connect with the diverse stakeholders in and outside the organisation. You have excellent organisation, facilitating and coordination skills. You will need this to be able to carry and supervise projects in the organisation. And to harvest quality awareness in the company.
• Master of Science degree in pharmaceutical sciences, chemistry, biochemistry or related discipline;
• Quality Assurance experience in the pharma and/or biotech industry
• Knowledge of GMP quality system and regulatory requirements (Eudralex, ICH)
• Knowledge of biological process development and manufacturing is a real asset
• Fluent in Dutch and English, written and spoken.