Karin Baas, M.Sc.

Quality & Risk Management zw-frl

Independent Consultant

QA Specialist

GxP consultancy - auditing - training

doing the right things right  —  efficiency and effectiveness in GxP

Independent Consultant QA specialist

doing the right things right  —  efficiency and effectiveness in GxP

Karin Baas has an extensive experience within several GxP environments;  within operations as well as within Quality Assurance. 

She worked within the Pharmaceutical Industry, Medical Device Industry and CRO business (pre-clinical, bio-analytical, phase I and late phase). After an extensive career as employee (1990-2014), Karin Baas started as an independent consultant in 2014. She shares her knowledge by providing a variety of services.

Experience / subject matter expert for:

- Management variety of QA departments (CRO and Medical Device, R&D and Operations)

- Preparation for Regulatory Inspection (both FDA and Dutch / local GxP authorities)

- Independent auditing (study, investigator site, CRO, subcontractor, supplier)

- QA / auditing clincial trials; Phase I (qualification and study)

- QA / auditing clinical trials; Phase II-IV (qualification and study)

- QA / auditing GLP and GCLP 

- Providing GxP training

- QA in vaccine development process

- Providing gap analysis and CAPA reports

- Assessing Quality Management Systems

- (clinical) Monitoring (CRA at Pharmaceutical Industry)

- Risk Management

- Privacy Legislation / DPIA

[be also referrred to LinkedIn profile]