Heike Psiorz

Quality Management of defined products at contract manufacturers to ensure that manufacturing, control and release of the relevant products are performed in a GMP and regulatory compliant manner and in accordance with the relevant pharmaceutical regulations and applicable laws. Responsible for QAA preparation, stability trending, CPV, audit support, CMO rating, assessment of complaints, deviations, CAPAs and change control.

Managed cGMP and compliance projects with significant importance to fulfill commitments with FDA. Performed Quality Risk Assessments. Active involvement in FDA audit preparation especially for the topic method validation and supplier qualification. Coordinated quality agreements with suppliers of excipients and assessed supplier’s supply chain. Involved in change control documentation to register excipients for drug products. Acted as matrix member in lifecycle management projects.

Experienced chemical and biopharmaceutical, analytical scientist with business knowledge acquired and demonstrated through Bachelor degree in Interdisciplinary Studies (B.I.S.) from Virginia Commonwealth University. Profound understanding of cGMP regulations and quality processes in quality control and regulatory affairs.

General Business, Project management, Marketing, and Analytical Chemistry

Organic and anorganic Chemistry, Biochemistry