Agnes Leuzinger

Agnes Leuzinger currently serves as a Qualified Person (QP) within the Department of Compliance at BakerHicks, where she plays a pivotal role in ensuring the integrity and regulatory compliance of pharmaceutical and healthcare products. Her responsibilities encompass overseeing Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) adherence, which are critical for maintaining product quality and patient safety. Agnes is deeply involved in the setup, maintenance, and review of Quality Management Systems (QMS), ensuring that all processes align with industry standards and regulatory requirements. Her expertise extends to the preparation and review of GxP documentation, including Product Quality Reviews (PQR) and Q-Agreements, which are essential for continuous quality improvement and supplier qualification.

In her role, Agnes actively manages supplier and customer qualification processes, conducts self-inspections, and prepares for external audits, demonstrating her commitment to transparency and compliance. She is also responsible for batch release and market authorization, ensuring that products meet stringent quality criteria before reaching consumers. Agnes’s proficiency in handling non-conformities and deviations highlights her meticulous approach to quality assurance and her ability to implement effective corrective and preventive actions.

Her skills in software quality assurance, staff training, and SOP development underpin her success in fostering a culture of quality and compliance within her team. Agnes’s pragmatic and collaborative approach, combined with her scientific background in natural sciences, enables her to navigate complex regulatory landscapes efficiently. Her dedication to open communication and building strong relationships with colleagues across diverse environments makes her an invaluable asset to BakerHicks’s compliance department, where she continuously strives to uphold the highest standards of GMP and GDP practices.