Acerca de Anastasiia
Senior Operations Leader with 10+ years of experience in global pharma & life sciences. Specialized in operational excellence, process optimization, cross‑functional alignment, quality compliance (GxP, QMS, SOP), audit preparation and large‑scale organizational transformation across Europe. Deep expertise in EU regulatory landscape, efficiency improvement, and cross‑regional stakeholder management.
Inglés
Bilingüe o nativo
Ruso
Bilingüe o nativo
Solo teletrabajo
Lleva a cabo sus proyectos principalmente en remoto
Experiencia
- Novartis Farmaceutica S.A.,Region Europe Operations Hubs Leadenero de 2024 - Hoy (2 años y 5 meses)Barcelona, Spain• • Build & lead high‑performing QA/operations hub; objective setting, capacity & capability planning• • Ensure timely market release compliant with cGMP/MAH; oversee deviations/complaints and market actions• • Own customer/stakeholder satisfaction loop; run OpEx initiatives and hub centralization roadmap
- Novartis GlobalOne Button Batch Release Change & Communication Manager / S4 HANA Solution Design Managerenero de 2022 - enero de 2024 (2 años)• • Global program management; change impacts; global procedures & training; validation with IT• • Onboarding support for entities; configuration mgmt; SteerCo reporting; risk/issue logs
- Novartis Neva (RU)Qualified Person; QA Operations Specialistdiciembre de 2021 - enero de 2024 (2 años y 1 mes)• • Batch certification; dossier compliance; audit/inspection readiness; complaints & investigations• • Change control, deviation mgmt, validation/qualification support; APQR; risk assessments
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Formación
- Qualified Person advanced trainingSechenov UniversityQualified Person advanced training
- Biotechnology EngineerState Chemical Pharmaceutical AcademyBiotechnology Engineer