IT Quality Specialist

Experienced Quality Specialist in the areas of pharmaceutical qualification and computer validation. I possess a broad toolbox for building efficient quality processes qua more than 10 years of industry experience topped with a number of certifications: from the classic ISO9000 auditor to EFQM Assessor, ITIL and LEAN Coach.
A few years back I made a jump from the Production to the IT division and am now mainly working with Computer Validation and related processes.

During my time as Compliance Manager in the production division I was a Speaker at ISPE Conferences on the topic of a LEAN approach to Good Engineering Practice (GEP).

At the time I am working on integrating the GxP Quality with the business other compliance issues and need for an efficient quality system.

Specialties:

Computer Validation
SAP Compliance (GxP, Segregation of Duties, etc...)
Qualification and Good Engineering Practice (GEP)