Experience / Resume

Karin Baas has an extensive experience within several GxP environments;  within operations as well as within Quality Assurance. She worked for the Pharmaceutical Industry, Medical Device Industry and CRO business (pre-clinical, bio-analytical, phase I and late phase).

Experience / subject matter expert for:

- Management of several 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

- QA / auditing clinical trials; Phase II-IV

- Providing GxP training

- Providing gap analysis and CAPA reports

- Assessing Quality Management Systems

- (clinical) Monitoring (CRA at Pharmaceutical Industry)

- Privacy Legislation / DPIA

quality & risk management zw-frl   —   © Karin Baas 2014