Zohre Fathinezhad

‏Set up and conduct quality control (QC) tests for Intravenous Immunoglobulin (IVIG) and Human Serum Albumin projects in alignment with the European Pharmacopoeia standards. Ensure QC procedures meet international compliance benchmarks by revising and updating standards as needed.

• Develop and manage SOPs, protocols, and reports, ensuring regulatory compliance. • Lead IPQC team, oversee QC activities, and validate tests per ICH Q2 (R1). • Perform COVID-19 tests, advanced assays, and impurity analysis on IVIG and HSA products. • Conduct stability studies, raw material testing, and document results per GMP/GDP standards. • Manage QC operations, including in-process and lot release testing.

Perform various laboratory tests including enzyme assays, ELISA, electrophoresis, SDS-PAGE, Western Blot, and protein analysis for monoclonal antibodies and biopharmaceutical projects such as Anakinra, Papilloguard, Ipilimumab, and Pembrolizumab. Assist in developing quality control tests for the Papilloguard HPV vaccine. Write standard operating procedures, protocols, and reports. Expertise in analytical, biochemical, and raw material testing, buffer preparation, and sampling in cleanroom conditions.

Working alongside genetic specialists, admitting patients, collecting blood samples, and performing laboratory tests on the blood and DNA of patients with genetic disorders to identify the type of disease and follow up on their cases .