The life science industry operates in a highly regulated environment with the highest demands on quality standards. In order to serve patients, the products must be of perfect quality in development and manufacture. This requirement covers the entire lifecycle of a product, from preclinical research (GLP), through development in clinical trials (GCP) to manufacture (GMP) and later distribution (GDP). The regulations in medical technology with the focus on CE registration will tend to be more in line with the pharmaceutical standard.
Quality management specialists must ensure compliance with the extensive requirements and quality systems, while at the same time preserving the companies' ability to act. In addition to extensive specialist knowledge, this task also requires a high level of communicative competence in order to communicate the requirements within different areas of the company.
Alina Kryzhanovskaya is our specialist for all positions in Quality Assurance.