Martin Überall

GMP/GDP/GLP audits of plasma suppliers (blood establishments / plasma centers) and service providers (testing laboratories / transport / warehouse companies) across international regions. Audit reports, audit findings, CAPA assessments. Qualification and requalification of plasma suppliers and service providers, ensuring full QA/RA regulatory compliance. Change & Deviation Management, Quality Assurance Agreements, KPIs. Full training and onboarding of new Auditors/Regulatory Specialists.

ISO and BRC standards implementation. Internal and external audits. Supervision of an in-process quality control laboratory. Risk analysis in production and warehouse. Recruitment and onboarding of new employees within quality and laboratory team. Leadership for quality initiatives. Quality representative to customers and regulatory stakeholders.

Supplier quality management and maintenance of the QMS for API manufacturing. Qualification and approval of suppliers of starting materials, intermediates and external APIs. Internal and external GMP audits. Change & Deviation management, CAPA, and complaints. Quality Assurance Agreements, GMP statements, and Annual Product Quality Reviews. GMP training sessions.

Quality compliance of pharmaceutical manufacturing documentation. Revision of manufacturing and control documentation according to GMP requirements. Compliance between manufacturing documentation and registered documentation. Assessment of a controlled documentation before final approval and release. Preparation of Annual Product Quality Reviews. Participation in project meetings as Quality Compliance representative. Revision of QA documentation and technical agreements.

Product presentation and customer assistance through clear and professional communication.

Conducted educational activities for kindergarten and elementary school students and served as a leader at a summer suburban camp.

Target drug delivery research.

During master's studies I focused on target drug delivery using fluorescence techniques (FLIM, FCS) and UV-VIS spectroscopy. Advanced theoretical and practical knowledge of chemistry and biochemistry. Diploma thesis: Solubilization in sonographic systems

Physical and analytical chemistry, biochemistry, immunology, microbiology, pharmacy and biotechnology. Bachelor thesis: Study of system based on phospholipids for sonographical application