職務の目的および主な業務内容 Quality Management Systemの中で、主に以下の業務を担う。 ・文書管理 (工場内の標準書及びGxP文書の管理) ・Regulatory関連（当局とのコミュニケーション、変更案件の薬事影響評価、本社CMCとの連携、当局監査のマネジメント） ・自己点検、課内点検のマネジメント ・ワクチンの国家検定 ・GSK StandardであるQuality Management System（GSKのstandard）のサイトへの導入 ・GxPにかかわる教育管理 上記の業務を実施しながら、生産現場を含むQA以外の部、Functionとも連携をとり、改善活動を実施していく。 上記業務のほかに、コンプライアンス課では、品質の取り決め書の作成、製品及び原料の品質QC実験用の規格基準設定、製品に使用される資材の規格設定及び取り決め書（品質契約書）作成変更管理、サプライヤーコントロール などを主とするGroupがあり、２つのGroupにてお互い協力しながら、業務を遂行している。よって、QMSの多岐にわたる業務にかかわることができ、将来のQA内外へのキャリアプランやDevelopmentにプラスとなる業務を担うことができる。業務の内容によっては、グローバルチームや他のサイトとのCommunicationをとることがある。 必要な条件 スキル ・GMPの知識 QMS概論の知識 ・英語（技術文書の読解、メールでのコミュニケーション、電話会議参加） ・PC skill（Word, Excel, PowerPoint） ・基礎的な問題解決能力 ・工場内外において相互協力、協調して作業を行う能力（コミュニケーション能力） 経験 ・製造業での品質業務経験 ・当局監査対応 学位/資格 ・薬学、化学、工学等の理系分野の学士以上 望ましい条件 スキル ・医薬品の生産工程、関連する原資材に関する必要とされる知識 ・安全衛生の理解
Job Description Govern the execution of Manufacturing Engineering activities in the External Supply Chain to assure the development, maintenance and continuous improvement of manufacturing processes and/or methods of manufacture which are capable of meeting and continuing to
About the role This role leads the BC Quality team in Japan based at the Takasaki factory and partners with Country MD for commercial support. The person is responsible for ensuring the design and implementation of
Job Description Summary A Lead Option & Upgrade Digital Product Specialist in Lifecycle solutions’ service marketing team is a key strategic position responsible for defining market and value propositions, articulating specifications, developing commercial strategy of solutions
To get the best candidate experience, please consider applying for a maximum of 3 roles within 12 months to ensure you are not duplicating efforts. Job Category Global Affairs Job Details About Salesforce We’re Salesforce, the
Sells a subset of product or services directly or via partners to a large number of named accounts/non-named accounts/geographical territory.Job Description: Responsible for identified banking accounts in Japan Quota carrying position (License Revenue). Qualification of prospects,
企業概要 Santenは、眼科医療に特化した130年の歴史を持つ製薬企業です。日本発のグローバル企業として60カ国以上に拠点を持ち、目の健康のために様々な革新的な治療法とデジタルソリューションを提供し、世界中の人々の視覚に関わる社会問題に取り組んでいます。 求人内容 Manage contract and monitor the progress of all licensing relationships. This includes(i) maintaining good relationship with license partners and thus open the possibility of improvement/modification of terms, access to portfolio additions, etc, (ii)
Objectives of the Position: Purchase Energy and utility products – defined here as Natural Gas, Industrial Gas, Electricity and Renewable Energy for Japan Lead the process of Negotiation, implementation and management of complex long-term agreements of
Role Details Business, Location: WITec, Tokyo, Japan Role: Field Service Engineer Reports to: Oi Service Technical Manager Direct Reports: None Primary Purpose: Oxford Instruments WITec is seeking an experienced Field Service Engineer with a strong both of
Position summary The occupational health physician will be expected to provide OH related care to the site J&J employees. Additionally, the physician would need to provide expertise in the prevention, evaluation, and management of conditions that
International SOS is the world’s leading medical and security services company with over 12,000 employees working in 1,000 locations in 90 countries. International SOS Government Services administers the TRICARE Overseas Program providing high-quality, accessible health care
Position Summary: Responsible for the development and analysis of contractual relationships including investigator grants including but not limited to drafting, negotiating, and finalizing agreements related to clinical trials and/or overseeing a Clinical Research Organization responsible for contract
Position Summary: Responsible for the development and analysis of contractual relationships including investigator grants including but not limited to drafting, negotiating, and finalizing agreements related to clinical trials and/or overseeing a Clinical Research Organization responsible for contract
Coach is a global fashion house founded in New York in 1941. Inspired by the vision of Creative Director Stuart Vevers and the inclusive and courageous spirit of our hometown, we make beautiful things, crafted to
About the Role: Grade Level (for internal use): 13 Department overview: Sales specialist is a key function within S&P Global with responsibility for client-facing activity including all aspects of business development for its specialist product line and region.
About the job The Red Hat Open Innovation Labs team is looking for an Engagement Lead to join us in Tokyo, Japan. In this role, you will use a variety of modern application development practices, along with
Blackstone is the world’s largest alternative asset manager. We seek to create positive economic impact and long-term value for our investors, the companies we invest in, and the communities in which we work. We do this
Who we are Are you looking for a dynamic career with excellent advancement potential at a global market leader? If so, consider Gartner, the worlds leading research and advisory company. Gartner delivers the technology-related insight necessary
External Skills Levy Manager Are you an experienced stakeholder engagement professional with looking for a new challenge? If youre looking for an exciting new opportunity to work in the world of Nuclear during a crucial period
Support the customer service operations including but not limited to evaluating, monitoring, analysing of results, and implementing any changes. Perform Korean language translation and proofreading where necessary. Respond and support Korean players issues via chat and
