・IT関連の調達 / IT procurement ・戦略的調達 / Strategic sourcing ・交渉戦略の立案と実行 / Planning and executing negotiations ・ITベンダーの管理 / IT vendor management ・IT予算のレビュー / IT budget review ・IT費用のモニタリング / IT cost monitoring ・IT費用の効率化アクションの立案と実行 / Planning and execution of IT cost efficiency actions
The injection dosage form pharmaceutical development study for designing and installation of the new manufacturing line, new facilities and new technology including the automation, barrier system, AI, Big data, MES and the cell technology, the authority submission and approval related work and the validation work based on the knowledge and skills of the injection manufacturing technology and the regulatory guidance.
The technology transfer to the manufacturing plant and the technology tasks for the process improvement and the investigation of the deviation and the claim.
【詳細は以下】 Responsible for planning and definng all requirement activity assoicated with SoC Product
・Support Market Requirements Definition ・Creation of System Security Req Document ・Managing all activity associated with device Threat Analsis and Risk Assessment (TARA)：Including Data Flow, Asset Identification, life cycle ・Determining security relevance. ・Support Identification of CM based on TARA ・Responsible for planning/ managing Work Product activity assoicated Security CASE ・Responsibl for submitting secuity case for assessement activity.