компания "astellas pharma" обязанности: contribute to the implementation of local affiliate qa objectives and plans as part of the overall qa strategy and plans. participates in the successful execution and implementation of global qa vision, mission, objectives and plans; actively contribute to the investigation and implementation of the ways in which the qa department can contribute to the compliance, efficiency and overall effectiveness of the affiliate; contribute to implementation of locally new initiatives, management tools and processes in cooperation with the regional qa function; ensure that processes, procedures and qa files are well documented and in an up to date and complete archive i.e. ‘audit/inspection ready’ status within respective field; contribute to establishment and maintenance of a local quality management system, including qds lifecycle management in corporate system; assist in the preparation and incorporation of applicable global and regional policies and sops into local procedures; perform training of affiliate staff in qa processes, systems and requirements, including management of training assignment in corporate system; prepare for, participate and respond to qa internal audits/affiliate internal audits, determine root cause for any identified non-conformities and establish and agree corrective action plans; contribute to qa oversight of local suppliers and third parties providing gmp/gdp services; contribute to establishment and maintenance of a local (non-regulatory) change control system; contribute to reporting of any potential significant quality issues to region qa and affiliate management; cross-functional collaboration and communication with affiliate ra/ma/pv/ qa, regional qa, 3pls and manufacturing sites. требования: minimum of degree in a science/health-related subject; intermediate/ upper-intermediate in written and spoken english; ability to deliver communication with clarity, impact and tailored to audience; computer literacy; minimum 1-2 years relevant experience in a comparable role in the pharmaceutical industry; quality assurance and/ or regulatory affairs experience within the pharmaceutical industry is essential. условия: competitive salary; official employment (the project lasts from 1 year); vhi; hybrid work schedule; interesting tasks in a team of professionals.
Адрес
Москва