製薬業界における品質管理のエキスパートとして、規制要件への適合と監査対応を主導するポジションです。医薬品製造プロセスの効率化と品質向上を実現し、GMP基準に準拠した品質管理システムの維持に貢献します。 · 内部および外部監査のサポートと対応策の立案・実施 · 品質管理システムの評価と改善提案の実施 · 規制要件に基づいた標準作業手順書(SOP)の作成と実装 · GMPリスク評価の実施と品質管理プロセスの最適化 · クライアントの品質管理部門と連携した問題解決と継続的改善活動の推進 · 製薬業界におけるCSV(コンピュータシステムバリデーション)または品質 ...

製薬業界における品質管理のエキスパートとして、規制要件への適合と監査対応を主導するポジションです。医薬品製造プロセスの効率化と品質向上を実現し、GMP基準に準拠した品質管理システムの維持に貢献します。 · ...

We put the diversity of our employees as a source of richness for the fulfillment of this vocation. · 製造委託先との製品に関する連携、技術移管及び移管後の維持管理を含む · ...

Lead and manage CMC regulatory activities including relevant cross-functional communication, providing guidance across the product lifecycle, and ensuring timely regulatory compliance with official guidelines. Develop and implement CMC registration strategies related to CTNs, NDA ...

We are seeking a Quality Management System (QMS) Specialist for a leading company in the medical device industry. This position is perfect for those who are passionate about quality management and want to make a difference in the medical device field. · ISO13485, QMS regulation, ...

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. · Lead the construction, ...

This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. · Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is drive ...

The Quality Assurance department (QA) is responsible for ensuring that intended products are delivered to customers in a stable manner. It establishes methods for quality assurance, provides these methods to related departments, and maintains them. It responds quickly to informat ...

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. · Establish and maintain ...

Internal Audit Manager is responsible for leading internal audit activities in Japan, focusing on US-SOX compliance. The role involves developing and improving the internal audit and control system, designing and improving audit methodologies, and evaluating and documenting inter ...

We are looking for an experienced engineer to lead the end-to-end development of medical devices, with a particular focus on upstream activities through design transfer. This role requires a strong foundation in design and verification, as well as hands-on involvement in project ...

We are seeking a Multilingual Medical Information Specialist to join our team. As a Medical Information Specialist, you will be responsible for providing medical information and answering inquiries from patients, healthcare professionals, and other external sources. You will also ...

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. · Collect and evaluate q ...

Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable A ...

This position plays a critical role in ensuring that the Company's business activities strictly comply with domestic and international laws, regulations, and internal policies. · Regulatory Adherence and External Relations · Regulatory Liaison: Serve as the primary point of conta ...

We are seeking a strategic and results-driven Global Head of Transformation Management to oversee and drive transformation across manufacturing, · supply chain, procurement functions.The ideal candidate will have experience in large-scale transformation projects, · a focus on opt ...

Drive the Future of AAV Gene Therapy · A Japan-based stealth biotechnology venture is developing a next-generation AAV gene therapy for vision restoration. · Lead mid-to-late phase CMC workstreams for AAV vector development · Drive process characterization, validation readiness, ...

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. · Internal, external audits · Trend a ...

At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. · p苦情担当スペシャリスト · tough punishment specialist · safety management department member performing following duties: kakujou shori: customer complai ...

We are looking for an experienced Tokyo based Japanese speaking Consultant, Financial Risk specializing in IFRS9 ECL related domain for the Japan and Asia market. · Lead IFRS9 ECL or other Risk management (ALM, Liquidity, etc.) solution implementation projects to meet client requ ...

At TÜV SÜD we are passionate about technology. Innovations impact our daily lives in countless ways, and we are dedicated to being a part of that progress. We test, we audit, we inspect, we advise. We never stop challenging ourselves for the safety of society and its people. We b ...