Quality Manager
As we continue to grow, we are looking to strengthen our Quality team with an experienced and motivated candidate who has a strong background in Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP).
The job
- First point of contact for day-to-day quality related matters
- Oversee and manage the quality management system (QMS) in alignment with GMP and GDP guidelines
- Ensure the development, implementation, and continuous improvement of training programs for all relevant personnel
- Ensure facilities and equipment are properly qualified, maintained, and validated
- Oversee the environmental monitoring system for the warehouse and manufacturing areas
- Implement and manage the annual calibration plan, validation plan and maintenance programs
- Responsible for coordinating and performing any recall operations promptly
- Manage and support risk assessments across processes and operations
- Ensure effective handling of change control, deviation, complaints and CAPA processes
- Perform qualification of suppliers and customers, and monitor them for continued compliance
- Approve subcontracted activities that may impact quality or regulatory compliance
- Conduct internal audits (self-inspections)
- Coordinate external quality audits of suppliers and subcontractors
- Host inspections from Competent Authorities
- Responsible for the disposition of returned, rejected, recalled or falsified products and if applicable, approve returns to saleable stock
- Support management reviews of quality performance and drive continuous improvement
- Review packaging batchrecords and quality reports
- Ensure a clear and timely communication and escalation of quality issues within the organization
- Foster a strong quality culture and promote awareness of regulatory requirements throughout
Your profile
- A minimum of 5 years of hands-on experience in a GMP and GDP-regulated environment
- Strong communication skills, both verbal and written
- Fluent in both English and Dutch
- Proficiency in MS Office applications (Word, Excel, PowerPoint)
- Highly organized with strong attention to detail
- Self-motivated and able to work independently
- Demonstrates a strong desire to learn and a commitment to continuous improvement
- Collaborative team player with a positive, proactive mindset
- Results-driven with a practical, hands-on approach
Our offer
- A dynamic and supportive work environment within a growing company
- A modern, well-equipped office located in the Evolis Business Park
- Competitive compensation package
- A challenging and engaging role that promotes a healthy work-life balance
Apply via jobs@novitan.com
