Frangeska Kitti

• Overseeing and controlling Quality Assurance activities in designated facilities (Aseptic filling, Oral formulations, Dry Powder for Inhalation) and continuous monitoring for GMP and Regulatory compliance, providing operational support and quality oversight, resulting in passing six external audits with no critical or major findings • Collaborating with cross-functional teams to investigate and document over 50 non-compliances/ emergencies, leading to identification of potential root causes, define and implement effective corrective actions timely and monitor post-implementation effectiveness, enhancing final product safety • Conducting organized quality reviews and approvals of batch related documentation and coordinating product release activities, ensuring product quality • Performing facility audits and participating in Internal Inspections, verifying and enforcing adherence to guidelines and company standards • Utilizing risk based approach along with collecting and analysing data, for the evaluation of the processes/systems/procedures, resulting to initiation, development and recommendations of improvements and application of mitigation controls, leading to increased productivity and reduced cost • Implementing, reviewing, managing of quality processes and GMP documentation resulting in decrease of non-conformances

• Followed in-process quality control procedures and performed accurate data entry of patient information (KIOS Database) to prepare collected specimens for testing and analysis • Conducted PCR and Rapid Antigen Testing of over 500 samples daily, directly contributing to the containment and mitigation of the SARS-CoV2 outbreak • Led small teams and trained 20 new testing associates in sample preparation, using proper swabbing techniques, enhancing team productivity • Facilitated cross-departmental communication, ensuring precise information transfer regarding sample statuses

Research project: “Predicting the clinical outcomes of stageT3 renal cancer patients”