A different kind of laboratory report – from the perspective of our employee Tamara Andreoli
I work in the quality control department, as Manager Development Analytics. Quality control deals with sampling, specifications and testing as well as organization, documentation and release procedures to ensure that the necessary and relevant tests are carried out and that neither materials are released for use nor products are released for sale or delivery until their quality has been assessed as being safe and flawless.
My field of activity does not only include the development of analytical methods. Important parts of quality control are for example validation and transfer activities which reflect a part of the life cycle of the analytical method.
Thus, validation of processes and methods says the following: It must be shown in a planned and documented process that procedures (e. g. manufacturing processes) and methods (e. g. analytical methods in quality control) achieve results that meet the requirements of the product and provide reliable replicable results.
In order to achieve these goals, daily work with various guidelines, as well as internal and regulatory requirements, is crucial for planning, implementation and successful completion.
In addition to the quality of the medicinal products / medical devices, the integrity of the data documenting the quality of the products and processes is an essential GMP requirement. Continuous and recurrent training is essential in the GMP environment to keep up to date with the latest regulatory requirements.
As a passionate developer and based on my experience as a project manager, I have the following belief: “Quality is reflected in cooperation”. Successful cooperation in interdisciplinary teams is essential for progress. Communication regulates the way we deal with each other and is what makes it possible to exchange information and identify needs. Together we can then work efficiently and, above all, sustainably on goals.
My team and I were the first in a Swiss pharmaceutical company to successfully validate the chromatography data software Empower 3 in the Amazon Cloud in compliance with GMP.
A dynamic and growing environment inspires me every day. My perseverance and enthusiasm for new things give me the opportunity to deal and relate with the unfamiliar.