With a background in Chemistry and specialized skills in validation and process development, my role at Minerva Knowledge and Risk Management centers on processes for a new innovative medical device, ensuring compliance and efficacy. Our team excels in creating robust processes that align with client specifications, ensuring high-quality standards and compliance.Previously, as a Senior Quality Investigator at Janssen, my analytical experience in root cause analysis was pivotal in authoring deviation investigation reports for cell therapy manufacturing. This experience honed my technical writing, fostering clear and comprehensive documentation that is crucial in the stringent field of pharmaceutical manufacturing. This experience underpins my current contributions, where I collaborate with cross-functional teams to develop robust protocols and documentation, significantly impacting product quality and safety.