Andrzej Sudenis

Computerized Systems Validation Specialist, IT Quality Manager, Project Quality Manager

Skilled in computerized systems validation, IT quality management, pharmaceutical quality assurance, GMP auditing and project management.

After his studies in Chemistry and Environmental Engineering at the University of Gdansk, Andrzej Sudenis was acquainted with a spectrum of validation and qualification activities in one of the biggest Polish pharmaceutical company.  

For 15 years, he held different positions in the pharmaceutical industry. As a Computerized Systems Coordinator, he supervised the development and implementation of the Company’s IT quality system that proved its robustness throughout several FDA audits. He also became a certified GMP auditor with a record of over 50 quality audits performed worldwide. In 2008 he took the role of the R&D Project Manager, in which he coordinated the development and registration of generic medicinal products.

In 2011 he has moved to Switzerland where, as a consultant, he provided his services in the areas of IT Quality and CSV to the big pharma companies.  

In his leisure time, Andrzej explores all dimensions of the world by cycling, scuba diving, paragliding and (most frequently) on his own feet. He also likes to read a book, watch a TV serial or get together with friends.

We believe that every action is an opportunity to improve. Therefore, we are dedicated to work with our customers to leverage their experience and mutually come up with validation solutions that are not only compliant but more effective than before. Quality and Productivity should be packed together. We know how to make it happen.

Certificates

Computerized Systems Validation using GAMP Training

Risk Assessment in the Pharmaceutical Industry ISPE Training

Audit Techniques in Pharmaceutical Companied Certification

PMI Certified Project Manager

Other pharmaceutical trainings such as cleaning validation, sterile process validation, pharmaceutical statistics

Languages

Polish (native)

English (fluent)

German (basic)

Russian (basic)