Quality Assurance Specialist /品質管理(QC)/品質保証(QA) 【製薬オンライン】製薬会社・製薬メーカー・製薬企業・医薬品・医療機器等の製薬・医療業界の求人転職サイト

受付時間 平日9時~20時まで 土曜9時~17時まで 03-6278-8721

製薬業界専門の転職・求人サイト 製薬Online.com
最終更新日: 2018年 12月 13日





Quality Assurance Specialist



・Provide Quality Oversight for all suppliers managed by the site in align to QMS (Quality Management System) requirements. This includes, implementing and managing ・Quality Agreements with local suppliers, management of change controls in case of supplier changes initiated by the site.
・Establish adequate controls and procedures for the receipt, handling, storage, and disposition of components, containers and closures, in-process materials, packaging materials, labeling, drug substances incl. intermediates and drug products incl. intermediates.
・Ensure that adequate processes and procedures are in place and followed for batch record review.
・Lead investigations with collaboration of other departments, generate deviation reports, perform trend analysis of root causes on a periodic basis.
・Manage corrective and preventive actions (CAPA) related to components, containers and closures, in-process materials, packaging materials, labeling, drug substances and drug products and associated facilities.
・Perform Annual Product Reviews/Annual Product Quality Reviews of each product manufactured on site. Utilize annual data to identity system or process improvements and ensure their implementation, as appropriate.
・Represent quality, provide quality oversight in complex projects or initiatives such as new product introduction.
・Lead continuous improvement initiatives and be act as a change agent to initiate such activities


  • ・Degree in Life Sciences, Engineering or related relevant discipline.
    ・Minimum of 5 years’ experience in the regulated pharmaceutical environment (pharma or medical device); preferably in a manufacturing site in quality (including QC) and/or manufacturing roles.
    ・Knowledgeable of Japanese and global authority quality and compliance requirements
    ・Knowledgeable in Industry Best Practices for quality and compliance related topics.
    ・Strong collaboration and cross-functional leadership skills to drive continuous improvement and promote knowledge sharing and implementation of best practices across the site and with other Quality functions on global and local level.
    ・Preferably have project management skills.
    ・Preferably have previous experience in Supplier Management, Risk Assessment, Deviation Management in pharma or med device environment
    ・Be ready to act as change agent
    ・Good Japanese and English communication skills


  • 応相談


  • 正社員


  • 埼玉


  • 当面なし


  • 450万~1100万