職務概要 DESCRIPTION : l このポジションの第一の役割は,製造管理者として当該製造所の製造管理,品質管理及び品質保証部門の活動を監督するとともに,海外製造所における問題解決や戦略策定,業の管理,コンプライアンスの推進,当局•製造販売業者との円滑なコミュニケーションを行うことなどである。 l 本ポジションは高度な GMP に関わる知識経験が求められる。 l チームのサポートとして他の GMP 業務や規制薬物管理業務を担当する。 l また,新規モダリティ関連製品の導入に際し,有益な知見•洞察を行うことも求められる。 法規制の順守に関する責任 /REGULATORY COMPLIANCE RESPONSIBILITIES: 当該製造所が以下に示す規制要件に遵守していることが求められる。 l GMP /GCTP l 薬局等構造設備規則 l 日本薬局方等の公定書 l 医薬品,医療機器等の品質,有効性及び安全性の確保等に関する法律 l 毒物及び劇物取締法等の安全に係る法律 l 麻薬及び向精神薬取締法 職務の詳細 ESSENTIAL DUTIES: 重大な逸脱•変更,承認書整合性確認,製品品質照査,マネジメントレビューなどに対する品質•薬事判断 責任役員への報告
This company has been in healthcare business for nearly 100 years, accelerating the journey to better diabetes care with the creation of their insulin products. You will be in charge of overseeing the outsourced finance and
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Join the team that is helping the most important clients for J.P. Morgan Payments business! As a solution center associate within our Payments business, you will be expected to build strong relationships with clients and prospects
Company Description IFS is a billion-dollar revenue company with 5000+ employees on all continents. We deliver award-winning enterprise software solutions through the use of embedded digital innovation and a single cloud-based platform to help businesses be
Company Description IFS is a billion-dollar revenue company with 5000+ employees on all continents. We deliver award-winning enterprise software solutions through the use of embedded digital innovation and a single cloud-based platform to help businesses be
Provide legal support across all lines of business enabling profitable growth while mitigating legal risks and assure adherence to governance policies, ethics, and country specific laws and regulations Career Level - IC3 Responsible for providing legal
Job Description Template As part of Risk Management and Compliance, you are at the center of keeping JPMorgan Chase strong and resilient. You help the firm grow its business in a responsible way by anticipating new and
Are you interested in being part of the team that makes direct impact to the firm’s business? You’ll play an integral role as a part of the Japan Operations organization, supporting to ensure the Japan businesses
At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your
About the department At Novo Nordisk we are experiencing a rapid growth in sales over the recent years and along with the wide range of new products to be launched, we are re-enforcing our production capability
About the department At Novo Nordisk we are experiencing a rapid growth in sales over the recent years and along with the wide range of new products to be launched, we are re-enforcing our production capability
About the department At Novo Nordisk we are experiencing a rapid growth in sales over the recent years and along with the wide range of new products to be launched, we are re-enforcing our production capability
At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your
ポジションを募集する背景 Technical Infra project manager plays a role to launch a project through analyzing application portfolio and tech currency, and proactively drive the project by leading engineers with understanding technology and system architecture. It will be
At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your
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We are creating a healthier world for all people. For more than 35 years, weve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and
