Quality Management – Do the things right
As quality management is very regulated in life science industry, it is important to have an extensive knowledge and experience in regulations and standards, customer requirements and common practice. Understanding the flexibility in the requirements, makes it easier to set-up a quality management system, which is in compliance and at the same time is efficient and brings value to the organization.
Many quality management systems are defined and implemented without taking into consideration the latest science on human behavior, why the industry is still suffering for too many human errors. There is a lot to gain by increasing the knowledge of human behavior in relevant part of the organization.
I have many years of experience working with different sizes of organizations in the life science industry worldwide and can help you and your organization with many different topics related to Quality Management for example:
- Quality Management Systems
- Implementation of IT solutions for Quality Management Systems
- Quality agreements and contracts for customers, suppliers and partners
- Training programs: Onboarding programs, GMP training etc.
- Clean Room Production
- Risk Management
- Process Validation
- Software Validation
- Data Integrity
- Deviations and Corrective Actions
- Systematic Problem Solving
- Human Errors
- Change Control
- Supplier Quality Management
- Quality Control Programs
I have a very process oriented and practical approach and find it easy to learn about new processes and technologies.
You are more than welcome to contact me for an informal discussion about your challenges and to hear more about how I can help you and your organization. I will always base my approach on where you are in your process, your regulatory landscape and take into consideration the size and complexity of your organization.