Umiejętności
Audit Reports
Batch Records
CAPA
Reklamacje
Deviation Management
Audyt zewnętrzny
GMP
Audyt Wewnętrzny
ISO 13485
ISO 14971
Microsoft Office
Pharmaceutical Law
Pharmaceutical Management
Pharmaceutical Packaging
Jakość produktu
Zapewnienia Jakości
Audyty jakości
Quality System
SOP authoring
Trackwise
ISO 9001
prawo farmaceutyczne
Track Wise
ISO 22716
Języki
angielski
dobry
Doświadczenie zawodowe
Quality Assurance Specialist
Work as Operational Quality Assurance Specialist in solid forms plant responsible for activities involving quality assurance and compliance with applicable cGMP regulatory requirements and company Quality Management System.
Main responsibilities:
- SOP's preparation and review
- batch record template review, batch record review
- Product Quality Review management
- internal and external auditor
- deviations and change control management
- preparation of technical agreements
- participation in quality projects
Main responsibilities:
- SOP's preparation and review
- batch record template review, batch record review
- Product Quality Review management
- internal and external auditor
- deviations and change control management
- preparation of technical agreements
- participation in quality projects
Szkolenia i kursy
ISO 13485 - Wyroby medyczne
Specjalizacje
Zarządzanie jakością
Zapewnienie jakości