OUR TEAM

Leonie Vangansbeke

Leonie is a Regulatory Compliance/ Quality Assurance consultant with strong technical skills, fast learning capabilities and a problem-solving mindset. Possesses strong analytical capabilities and excellent communication skills. She has the ability to work quickly and accurately, take initiative, when required.
Is an ideal team-member due to her working spirit, sense for initiative and friendliness. Is always up-to-date with professional knowledge, expertise, legislation, best practices, excellent knowledge in GxP requirements and other regulations.
Has a proven ability to engage constructively with colleagues at all levels across different departments to deliver objectives.

These specifications ensure that projects by Aurélia will be handled accurately and successfully.

Expertise

Medical devices
Combination products
In-vitro diagnostics
Pharma
Food
Cosmetics
Quality Risk Management
Regulatory Compliance
Training
Validation and Qualification
Project Management

Certificates

Prince 2 Foundation
Internal auditor ISO 9001 : 2015
Internal auditor ISO 13485 : 2016
Supplier auditor

Helene Symens

Hélène is our senior Quality Assurance consultant who is specialized in revamping Quality Management Systems. She is an ideal team member, has a good working spirit, and will handle projects in a correct and pragmatic manner.

Expertise

Medical devices
ISO 13485
21 CFR 820, 803, 806
Training
CE marking
CAPA processes
Complaint processes
ESH Management
Validation
Quality Assurance

Certificates

CESS and qualification certificate
ISO 9001 and 13485