Alireza Zarei

Alireza Zarei is the Founder of Pharmuni and CEO of Zamann Pharma Support GmbH, bringing extensive hands-on experience in pharmaceutical quality management, GMP compliance, validation, and digital transformation. Since 2017, he has led Zamann Pharma Support, supporting pharmaceutical and medical-technology organizations with quality systems, regulatory compliance, computerized systems, and innovative digital solutions.

Throughout his career, Alireza has worked on international projects for major life-science organizations including Takeda, BioNTech, Boehringer Ingelheim, Fresenius Medical Care, and Roche. His work has ranged from laboratory quality control and pharmaceutical investigations to global Computer System Validation (CSV), LIMS implementation, data integrity, audit readiness, organizational change management, and quality-system harmonization. At Takeda, for example, he led validation activities for a LabWare LIMS implementation, including interfaces, migration planning, Annex 11 compliance, and laboratory readiness. At BioNTech, his responsibilities included global LIMS deployment, computerized-system assessments, GMP quality-process harmonization, validation documentation, and digital Quality Unit implementation.

His professional background also combines quality management with learning and digital innovation. He has developed global learning and training concepts, including a Learning Management System approach supporting more than 40,000 end users, and has led global validation, TrackWise, environmental-monitoring, and change-management initiatives.

Core areas of expertise include:

• Quality Management and GMP Compliance
• Digital Transformation in Pharmaceutical Operations
• Computer System Validation (CSV) and GAMP 5
• Laboratory Information Management Systems (LIMS)
• eQMS, Data Integrity, and computerized-system compliance
• Learning Management Systems and professional training
• CAPA, deviations, investigations, and risk management

Alireza is also a Certified Quality Management Officer and has specialist knowledge across pharmaceutical quality assurance, FDA and EMA expectations, laboratory technologies, TrackWise, LabWare, and digital quality systems.

Through Pharmuni, he combines this industry experience with a focus on making practical pharmaceutical knowledge, GMP training, and career development more accessible to professionals entering or progressing within the life-sciences industry.