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
JOB SUMMARY The position is responsible for implementing quality assurance processes that meet the company’s mission and brand standards, target customer needs, ensure employee satisfaction, and focus on continuous improvement at the property level. This position
Mujin has transformed the field of industrial automation with its innovative robot control technology and is currently revolutionizing supply chains worldwide. Today, we are rapidly expanding our business both domestically and internationally, serving clients from Japan
Reporting to the Hinseki and lead in handling and handling QMS as well as other quality activities. Ensure effective compliance for companys products Client Details * Global medical device company specializing in the oncology area *
Job Description Job Summary: To ensure that clinical supplies are stored and distributed in accordance with Fisher Clinical Services (FCS) approved procedures and policies, cGMP, cGDP, and regulatory requirements. Maintain the FCS Japan Quality System in
職務 概要 Position Summary : 1. The launch of new technology, products and technical transfers. 2. The validation process and execution (Process and Cleaning Validation). This includes lifecycle management of products (including continuous improvement). 3. Packaging
( 概要 ) 日本国内で治験を実施するためのオペレーションチームリーダーとして,国内外のステークホルダーとの協議•交渉など,エキスパートとしてのコミュニケーションを通じ,品質を確保した臨床試験を計画通りに遂行する。 ( 具体的な業務例 ) •試験実施施設の選定戦略,症例組み入れプラン•戦略の作成及び実行 •試験遂行のための現場の責任者としてモニターへの指示及びモニターへの助言 •試験全体の進捗および GCP , SOP に沿った臨床試験の実施と品質の確保 •国際共同試験の場合,海外担当者からの指示の正確な把握及び協議を含めた円滑なコミュニケーション •試験における Risk & Issue Management •治験契約締結交渉,データ固定, GCP • SOP に基づくモニタリングに対するモニターへのフォロー •チームビルディング,ステークホルダーマネジメントによるチーム作り •社内の改善活動 / Task force team への参加 •試験全体の予算の管理 Position Summary: The
( 概要 ) 日本国内で治験を実施するためのオペレーションチームリーダーとして,国内外のステークホルダーとの協議•交渉など,エキスパートとしてのコミュニケーションを通じ,品質を確保した臨床試験を計画通りに遂行する。 ( 具体的な業務例 ) •試験実施施設の選定戦略,症例組み入れプラン•戦略の作成及び実行 •試験遂行のための現場の責任者としてモニターへの指示及びモニターへの助言 •試験全体の進捗および GCP , SOP に沿った臨床試験の実施と品質の確保 •国際共同試験の場合,海外担当者からの指示の正確な把握及び協議を含めた円滑なコミュニケーション •試験における Risk & Issue Management •治験契約締結交渉,データ固定, GCP • SOP に基づくモニタリングに対するモニターへのフォロー •チームビルディング,ステークホルダーマネジメントによるチーム作り •社内の改善活動 / Task force team への参加 •試験全体の予算の管理 Position Summary: The
The Construction Project Manager is responsible for managing and overseeing construction engineering, planning, and design of all strategic asset investments of Maersk L&S facilities in APA. Working closely with cross-functional teams and external consultants to deliver projects
BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our
Cochlear is the global market leader in implant hearing solutions. Cochlears mission is to help people hear and be heard. Around the world, more people chose a Cochlear-branded hearing implant system than any other. A Cochlear
Job Description Summary Enable and drive ethical business conduct through effective implementation of the ERC program (Local training, Disseminate policy/guidelines, remediation, and communication). And continuously seek opportunities to simplify NPKK’s rules and SOPs to support principles-based
HARMAN’s engineers and designers are creative, purposeful and agile. As part of this team, you’ll combine your technical expertise with innovative ideas to help drive cutting-edge solutions in the car, enterprise and connected ecosystem. Every day,
About Four Seasons: Four Seasons is powered by our people. We are a collective of individuals who crave to become better, to push ourselves to new heights and to treat each other as we wish to
Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department.
Job Description Summary 責任範囲内の品質側面を管理し、運用業務がcGMP(現行適正製造基準)、品質保証契約、規制要件、およびサンド品質マニュアルに準拠し、関連する標準操作手順に従って実施されていることを確認する責任があります Job Description Major Accountabilities ~ 外部委託先の生産および試験活動の監視により、データの整合性とeコンプライアンスを含むcGxPへの準拠が保証されます ~ 逸脱管理、変更管理、苦情調査、CAPA ~ APQRレビュー ~ QAA作成・改訂 ~ Auditサポート ~ 製造所からのバッチリリースを保証 Key Performance Indicators 責任範囲内の品質側面を管理し、運用業務がcGMP(現行適正製造基準)、品質保証契約、規制要件、およびサンド品質マニュアルに準拠し、関連する標準操作手順に従って実施されていることを確認する責任があります Work Experience ~工場あるいは本社におけるQA業務 ~API又は製剤工場における製造又はQC試験業務 Skills ~GMPの基本理解 ~承認書の内容理解 ~QA(品質保証)実務経験 ~技術的専門知識 Language 英語 Skills Desired
Job Description Summary ・Develop the medical expert engagement plan(s) in assigned therapeutic area(s) and local areas under the direction and agreement of the Group manager. Job Description Develop the medical expert engagement plan(s) in assigned therapeutic area(s)
At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our
JOB SUMMARY On the basis of Sanofi quality policy and Japanese regulations, make available to customers high quality products and services through promoting Quality Assurance activities strongly and leading / supporting Japanese Contract Manufacturing Organization in
Description 【Position Summary】 This person oversight and/or manage all the financial transactions in Sales Department, including CIW, Consumer Promotions, and SG&A, providing the visilibity of Plan and Actuals, while ensuring the compliance in these transactions. 1.