Wohlen, Aargau, Switzerland
Detail-oriented life sciences professional with extensive experience in GMP-regulated sterile cytostatic manufacturing. Proficient in compliance-driven processes, documentation control, and validated systems. Currently pursuing a CAS in Regulatory Affairs, demonstrating a strong understanding of EU MDR and Swiss MDR requirements. Skilled in risk-based decision-making and ensuring medical device lifecycle compliance.
•Executed aseptic manufacturing of patient-specific cytostatic products within a GMP-regulated environment, ensuring strict adherence to quality and compliance requirements. •Operated and supported Apoteca robotic systems (Loccioni), ensuring process control, traceability, and documentation accuracy in automated production. •Managed dosage, therapy intervals, and regimen documentation using BD CATO / BD Cato Onco, maintaining data integrity in controlled systems. •Performed GMP documentation activities, including logbook verification and batch-related administrative checks to maintain audit readiness. •Processed returned medications and conducted cost reconciliation via SAP, ensuring traceability and compliance with internal quality procedures. •Collaborated with production, administrative, and quality stakeholders, gaining cross-functional exposure relevant to regulated product environments.