Luis Miguel Campos Calvo
Qualified Person & Quality Assurance Manager @Siemens Healthineers
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WORK HISTORY
Qualified Person & Quality Assurance Manager @Siemens Healthineers
Certification and release of medicinal product batches according to the Marketing Authorization.• Oversight of Quality Management System.• Ensuring compliance with cGxP for manufacturing, testing, and release activities.• Prepare for and manage regulatory inspections and audits, ensuring that all documentation and practices meet the required standards.• Manage the Self-inspection program including adherence to the schedule and preparing the schedule using a risk-based approach.• Partnering with management to monitor quality performance, identify risks, and lead improvement initiatives.• Lead investigations into quality issues, deviations, and complaints, implementing corrective and preventive actions (CAPA) as needed.• Co-operation and communication with internal and external customers.• Subject Matter Expert in Sterile and Aseptic preparations (Radiopharmaceuticals).
EDUCATION
Ephos (School of PharmaStudies)
Máster en Industria Farmacéutica y Registro de medicamentos
Universidad de Santiago de Compostela
Licenciatura en Farmacia
Colegio Apóstol Santiago
Bachillerato de Ciencias de la Salud, Servicios sanitarios/Ciencias de la salud, general
University of Cambridge
English as a second language
EAE Business School
Master of Business Administration - MBA, MBA
SKILLS
ABOUT LUIS MIGUEL CAMPOS CALVO
Executive MBA Pharmacist and Pharmaceutical Industry Master with over a decade of experience in Operations and Quality within GMP-regulated pharmaceutical environments. Currently serving as a Qualified Person and Quality Manager at Siemens Healthineers. Proven expertise in batch certification under EU and UK regulations, regulatory inspection readiness (MHRA, EMA, FDA), and end-to-end quality oversight across manufacturing, validation, and supply chain operations.Decisive, analytical, and skilled at cross-functional coordination, with a strong ability to anticipate and adapt in dynamic regulatory settings.
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