A KEY TECHNOLOGY FOR EXPERTS.
In recent years, biology, chemistry, medical technology and pharmaceuticals have increasingly overlapped and are increasingly merging. From this, a new combined key technology with enormous growth potential has emerged with life sciences.
The life science sector is developing rapidly worldwide and therefore innovations from complex research and development processes are important growth drivers. In addition, companies operate within a framework of demanding laws and regulations.
You can find details on this in our overview of job descriptions.
ROSA is the contact for qualified experts for your innovations
Modern pharmaceutical products and medicines are absolute high-tech products that serve the greatest good of human, health. In order to guarantee the appropriate development of such high-tech products, you need not only the latest technology but also highly qualified experts who, with their commitment and innovative spirit, pave the way for the medical products of tomorrow.
Production in the pharmaceutical sector poses an enormous challenge for companies, since the highest standards of hygiene and purity are of crucial importance for the products. Highly automated production lines are required for sterile production, control and packaging of a wide variety of products, which always follow the guidelines of Good Manufacturing Practice (GMP).
While the Drug Safety department (pharmacovigilance) deals with the continuous and systematic monitoring of finished medicinal products for the purpose of drug safety, the focus in the Medical Affairs area is on risk assessment. It is of essential importance to identify any risks and medical dangers, to evaluate them accordingly and to record them in the context of medical reports. The Regulatory Affairs department deals with the approval of new products with regard to product and patient safety. This includes maintaining contact with the responsible authorities in order to ensure compliance with legal requirements and to be able to react to any changes as quickly as possible.
All products of the pharmaceutical and medical technology industry are of course subject to the highest quality standards, which must always be observed. Mistakes immediately mean huge financial risks and of course even worse the risk of damage to people. The protection and safety of people are always the top priority. In order to ensure this accordingly, a well-functioning quality management system and its optimization in every respect is of the utmost importance.
In the pharmaceutical industry, the qualification of systems and the validation of processes is elementary work that must be carried out by the appropriate experts. Within Europe, qualification is documented and recorded in the stages of design qualification (DQ), installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ). Qualification and validation is not only required for new systems and processes, but is always carried out when changes are made to the facility, equipment and processes to ensure that the changes do not have a negative impact on product quality.