As part of a project in the regulated pharmaceutical environment, the employee worked as a quality analyst specialising in data integrity and quality management systems (QMS). The aim of the project was to ensure data integrity in production and quality assurance and to continuously optimise quality-relevant processes. She independently checked production and quality data for accuracy, completeness and consistency and further developed procedures for targeted data monitoring.

A central component of her work was the preparation, monitoring and follow-up of audits and inspections. This also included the processing of catalogues of measures and the creation of SOPs, guidelines and training documents. She also independently organised training courses to raise awareness of data integrity within the company. In the area of deviation management and CAPA, she analysed causes, derived appropriate measures and evaluated their effectiveness in close coordination with various specialist departments.

She also took on the management of special projects with a focus on process optimisation and quality assurance and reported regularly to project management. Another focus was the introduction and maintenance of an environmental monitoring system, particularly with regard to regulatory requirements and EM documentation. Throughout the project, she worked closely with cross-functional teams to identify quality problems at an early stage, implement sustainable solutions and increase process efficiency in the long term.