In pharmaceutical distribution companies in the Republic of Moldova, I manage and maintain Quality Management Systems in accordance with GDP requirements. I develop and review SOPs and quality documentation, and handle deviations, root cause investigations and CAPA follow-up.
I planned, organized and conducted approximately 10 internal QMS/GDP audits, and participated in 4 regulatory inspections by AMDM. My inspection work included preparation, documentation, responses to observations and CAPA follow-up.
I also support supplier qualification, risk assessment, and qualification and validation activities. For medicinal products and dietary supplements, I monitor storage conditions, temperature records and product traceability, and participate in GVP/pharmacovigilance audits.
