Quality Assurance (QA)

Inge Kuhlmann Goddik

Contact

Inge Kuhlmann Goddik, Head of department, Quality Assurance
T. +45 32688467 @. INKG@ssi.dk

Purpose

Quality Assurance department (QA) is responsible for developing and maintaining the strategic, tactical and operational part of the quality management system. This includes ensuring compliance of project activities within technical & IT systems, investigational medicinal products, preparedness and commercial products for distribution.

Tasks

QA ensures that SSI's quality management system complies with current GxP guidelines for pharmaceutical and biological products in accordance with national and international requirements. On the operational level QA reviews and approves GxP documentation relating to production, analysis, technical & IT systems.

QA releases investigational medicinal products for clinical trials and preparedness and commercial products for distribution. It is QA's responsibility that SSI and GxP suppliers meet requirements through self-inspections, audits and quality agreements.