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。 · ...

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 ...

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 ...

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, ...

The CMC RA Manager will lead and manage CMC regulatory activities, develop and implement CMC registration strategies, and support the development of the CMCRA team. The ideal candidate will have +10 years of practical experience with CMC-related roles, experience drafting and com ...

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 ...

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 ...

+Leads the identification, design, and implementation of quality assurance programs and initiatives to improve process efficiency. · ...

· Supports the development and continuous improvement of business quality management practices and facilities. · Automotive electronic connector parts (connectors, cables) related new product development project quality technical work. · ...

The QAQC Assistant Manager is responsible for leading non-conformance management and customer complaint investigation. They will assist the Quality manager with implementing overall quality system plans and coordinating activities. · ...

+This is a QAQC Assistant Manager position at BASF in Japan. The role involves leading non-conformance management and customer complaint investigation, assisting quality manager with implementation of quality system plans, and acting in accordance with quality control procedures. ...

Internal Audit Manager to lead audit activities in Japan, focusing on US-SOX compliance. Develop and execute annual audit plans, including US-SOX compliance audits. Design and improve audit methodologies aligned with J-SOX where applicable. Evaluate and document internal controls ...

Quality Control (QC) Lead reports to Head of Saitama Site and oversees the QC department to ensure product quality from incoming materials to outgoing products based on GMP and Japan Pharmacopeia (JP). The position is part of Site Leadership Team (SLT) and oversee entire activiti ...

We are seeking a Quality Control Lead to join our Saitama Site leadership team. As a key member of our site leadership team, you will oversee the quality control department to ensure product quality from incoming materials to outgoing products based on GMP and Japan Pharmacopeia ...

+Quality Control (QC) Lead reports to Head of Saitama Site and oversees the QC department to ensure product quality from incoming materials to outgoing products based on GMP and Japan Pharmacopeia (JP). · +Lead and manage the QC team. · Ensure that the QC team is adequately train ...

We are seeking a RegulatoryAffairs Specialist to join our team at JohnsonandJohnson.The successful candidate will be responsible for maintainingand managing regulatory approvals for pharmaceutical products including surgical suturesand adhesives. · ...

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, 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 · Internal Controls and Policy Development · Operational ...

+ · The company seeks an experienced professional for its regulatory affairs team responsible for maintaining management of Japan general surgery field products including sutures tissue adhesives etc. ...

+This role involves maintaining regulatory approvals for general surgery products including sutures and tissue adhesives. · +Promptly managing regulatory compliance activities across various regions. · Establishing strong relationships with key stakeholders within local authoriti ...