Опубликовано: 06 Сен 2021
Purpose & Scope:
Project manages and executes tasks associated with the Change Control quality system following management guidance and oversight. Maintains & monitors the applicable change control system, associated databases to ensure that records are in a compliant state and generates metrics for routine reporting. Assures Astellas compliance with global regulations, corporate standards and SOPs for Change Control and general quality systems. Supports additional Quality Assurance initiatives as requested.
Essential Job Responsibilities:
Executes tasks associated with general quality systems, and more specifically, the Astellas global change control quality system. Project manages any assigned change control related activity and deliverables to completion in partnership with global Astellas quality assurance affiliates and external business partners as applicable. Assists, develops and manages timelines to maintain compliance to Astellas project timelines, SOPs, standards and global regulatory requirements.
This role reports to the QA Commercial Quality Representative of Russia as applicable. Works closely with other areas such as Regulatory Affairs, PV, Legal, Commercial, Supply Chain, Market Access, Global Project Management and Product and Project Management.