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Simona KasaSK
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Simona Kasa

@simonakasa

Corporate Quality Plasma Auditor at Octapharma, conducting supplier audits and supporting plasma quality compliance.

Austria
Message

At Octapharma Pharmazeutika Produktionsges.m.b.H., I conduct plasma supplier audits across Europe and the United States. I prepare audit reports and manage CAPAs, change controls, Quality Assurance Agreements, SOPs and plasma-related specifications.

I maintain and update the Plasma Master File in alignment with FDA and EMA requirements, and perform plasma-related risk assessments. I also participate in FDA and European health authority inspections at Octapharma sites.

At IQVIA, I provided evidence-based medical information to healthcare professionals across EMEA and reviewed clinical data and scientific literature to prepare accurate, compliant responses. I also contributed to pharmacovigilance activities and supported quality improvement as EMEA Quality Lead.

Earlier, at Vienna General Hospital (AKH), I participated in clinical research focused on pulmonary hypertension therapies and supported clinical data evaluation and analysis. I hold Doctor of Pharmacy and Master of Pharmacy degrees from the University of Veterinary and Pharmaceutical Sciences.

Experience

Work history, roles, and key accomplishments

Octapharma Pharmazeutika Produktionsges.m.b.H. logoOP
Current

Corporate Quality Plasma Auditor

Oct 2022 - Present (4 years 1 month)

Conducted 100+ qualification, routine and follow-up audits of plasma suppliers across Europe and the United States. Trains and supports new auditors, prepares audit reports, CAPAs, and maintains the Plasma Master File in alignment with FDA and EMA requirements.

IQVIA logoIQ

EMEA Medical & Pharmacovigilance Specialist / EMEA Quality Lead

Aug 2019 - Sep 2022 (3 years 1 month)

Provided evidence-based medical information to healthcare professionals across EMEA on vaccines, HIV, respiratory diseases, immunology, oncology and neurology. Contributed to pharmacovigilance activities and supported process standardisation and quality improvement initiatives as EMEA Quality Lead.

Vienna General Hospital (AKH) logoVA

Young Researcher, Department of Cardiology / Pulmonary Hypertension Unit

Vienna General Hospital (AKH)

Oct 2016 - Sep 2018 (1 year 11 months)

Participated in clinical research focused on pulmonary hypertension therapies. Collaborated with clinicians and researchers and supported clinical data evaluation and analysis, contributing to scientific publication activities.

Education

Degrees, certifications, and relevant coursework

US

University of Veterinary and Pharmaceutical Sciences

Doctor of Pharmacy, Pharmacy

Doctor of Pharmacy degree with a doctoral thesis on pharmacological treatment of pulmonary arterial hypertension, in collaboration with Vienna General Hospital.

US

University of Veterinary and Pharmaceutical Sciences

Master of Pharmacy, Pharmacy

Master of Pharmacy degree with a master thesis on schizophrenic phenotypes and metabolic dysbalances.

Tech stack

Software and tools used professionally

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