Job Title - Quality Assurance Auditor
At one of our biggest clients in the area of Nijmegen, a large diversity of biological and pharmaceutical products are produced, tested, packed and released. The Quality Systems and Compliance department, as part of the Quality Organization, is responsible for maintaining the Quality Systems and compliance to cGMP (Good Manufacturing Practices).
- Primary focus: Responsible for Deviation management system
- Support all users at the site in case of questions or issues to ensure adequate and compliant processes
- Measures and reports system performance (metric generation regarding overdue records)
- Responsible for informing escalating system issues to higher management, and responsible for resolving system issues
- Contact with global Quality for improvements and resolving issues
- Takes lead in improvement actions within Deviation management system
- Support the department in the maintenance, execution and improvement of other routine tasks e.g. routine tasks in documentation management, change management and deviation management system, support the Supplier management team in writing TQAs, ST maintenance and supplier changes, support during inspections.
- HBO / Msc working and thinking level.
- A couple of years' industry experience in GMP/Quality related role, experienced in GxP.
- Knowledge of internal and external compliance requirements and quality guidelines
- Project management understanding and capable to fulfil project team roll
- Speaks Dutch and English on a fluent level
- Self-starting, can do attitude
- Results oriented and eager to learn
- Actively listen and seek to understand differing perspectives
- Analytical, data and solution driven
- Works independently when task is clear
- Focus on delivering value for internal and external customers
- Clear communicator in writing and in speech (Dutch and English)
- People-oriented, interpersonal skills
For more information, and to apply, feel free to send me a message at j.vanbaalen(@)progressive-nl.com with your most recent CV + Cover letter!