пропозиції роботи
Joanna Rozen
QA Expert
Warszawa,
mazowieckie
Dołącz do GoldenLine i obejrzyj pełny profil tej użytkowniczki
Zobacz pełny profil
Umiejętności
CAPA
Kontrola zmian
GMP
GxP
Przemysł farmaceutyczny
Zapewnienia Jakości
Audyty jakości
Quality System
Regulacje
Zarządzanie relacjami
Sop
Subcontractor Supervision
Szkolenie
Języki
angielski
biegły
Doświadczenie zawodowe
QA Expert
Quality support of Business Development and Licensing in BD&L projects
(QAA preparation, auditing, risk assessment, incidents)
Internal auditing
Audit/inspection support & readiness (Regulatory & PV)
Quality support for clinical trials
QMS introduction maintenance and monitoring
Quality Improvement & CAPA management and monitoring
Acting/leading actions for Quality incidents ( quality incidents, recall/suspension, global escalation)
Employees’ Quality management trainings
(QAA preparation, auditing, risk assessment, incidents)
Internal auditing
Audit/inspection support & readiness (Regulatory & PV)
Quality support for clinical trials
QMS introduction maintenance and monitoring
Quality Improvement & CAPA management and monitoring
Acting/leading actions for Quality incidents ( quality incidents, recall/suspension, global escalation)
Employees’ Quality management trainings
Medicine Quality & Compliance Manager
Design, maintenence & improvement of Quality Management System
Document control management
Quality Improvement & CAPA management
CRO quality management
Audit/inspection support
Document control management
Quality Improvement & CAPA management
CRO quality management
Audit/inspection support
Senior quality assurance specialist
Quality Management System introduction & maintenance
SOP database oversee
Conducting self-inspecion(L1)
Logistic Service Providers oversee
Conducting 3rd Party audits & CAPA supervision (Logistic Service Providers)
Interim support for Multi Market Warehouse
Quality Assurance Agreements preparation & maintenance
GDP related incidents management & consulting (clinical studies & distribution)
Conducting QMS trainings for sales staff & office emloyees
Support during L3 & Health Authorities audits/inspections
Suspension/Recall actions coordination
SOP database oversee
Conducting self-inspecion(L1)
Logistic Service Providers oversee
Conducting 3rd Party audits & CAPA supervision (Logistic Service Providers)
Interim support for Multi Market Warehouse
Quality Assurance Agreements preparation & maintenance
GDP related incidents management & consulting (clinical studies & distribution)
Conducting QMS trainings for sales staff & office emloyees
Support during L3 & Health Authorities audits/inspections
Suspension/Recall actions coordination
Quality assurance specialist
Quality Management System introduction & maintenance
Conducting internal quality audits (L2) & CAPA supervision
Conducting 3rd Party audits & CAPA supervision (Logistic Service Providers)
Co - auditing in repacking site audits
Quality Assurance Agreements preparation & maintenance
Complaints' process management (back-up)
GDP related incidents management (clinical studies & distribution)
Quality assurance support for logistics & distribution
Conducting QMS trainings for sales staff & office emloyees
Relation management with Health Authorities
Conducting internal quality audits (L2) & CAPA supervision
Conducting 3rd Party audits & CAPA supervision (Logistic Service Providers)
Co - auditing in repacking site audits
Quality Assurance Agreements preparation & maintenance
Complaints' process management (back-up)
GDP related incidents management (clinical studies & distribution)
Quality assurance support for logistics & distribution
Conducting QMS trainings for sales staff & office emloyees
Relation management with Health Authorities
Regulatory affairs specialist
Z.F.Polpharma S.A
Documentation preparation related with EU upgrade
Dossier audits(contract manufacturing & product transfer)
Relation management with Health Authorities
Regulatory consulting for marketing & R&D regarding respiratory products
Dossier audits(contract manufacturing & product transfer)
Relation management with Health Authorities
Regulatory consulting for marketing & R&D regarding respiratory products
Edukacja
Quality Management, studia podyplomowe
Warsaw School of Economics
Pharmacy/ pharmaceutical analytics, magisterskie
Medical Univercity of Warsaw
Specjalizacje
Zarządzanie jakością
Zapewnienie jakości
Grupy
Akcjonariusz & Inwestor
Grupa dla akcjonariuszy, inwestorów, CFO, praktyków i pasjonatów, osób dla których istotne jest kreowanie wartości dla właścicieli/akcjonariuszy
Auditorzy Systemów Zarządzania
Grupa osób związanych z auditowaniem Systemów Zarządzania takich jak ISO 9001, ISO 14001, PN-N/OHSAS 18001, ISO 27001, ISO/TS 16949, ISO 22000 (IFS, BRC), ISO 13485, ISO/IEC 17025, IRIS itp.
audyt
Audyt wewnętrzny i zewnętrzny, audyt wykorzystania środków UE, egzaminy i certyfikaty w audycie.
BHARAT
Grupa miłosników kultury, filozofii indyjskiej a także osób, które aktywnie chca promować wymianę społeczną i gospodarczą pomiedzy Polską a Indiami
Chemia kosmetyczna
Grupa dla wszystkich zainteresowanych chemią kosmetyczną. Celem istnienia nowo powstałej grupy jest stworzenie platformy umożliwiającej m.in. wymianę poglądów, opinii i doświadczeń, a także naw
Faceci gotują
Grupa skupiająca miłośników dobrego jedzenia, przygotowanego własnymi rękoma. Stworzona po to, by pomóc zapracowanym, pasionym głównie na fastfoodach mężczyznom.
Uwierzcie - gotowanie nie jest trud
