Site Lead Power User for E-Validation System / Engineering Compliance

ACCOUNTABILITIES Develop and manage project budgets, ensuring that all expenditures are in accordance with approved budgets. Manage project risks, ensuring that risks are identified, assessed, and mitigated in a timely manner Provide regular project status updates to senior management and other stakeholders. Ensure compliance with all applicable regulations, guidelines, and policies. Provide regular management up-dates and act as an enabler for individual project teams. Use project management methodologies and skills to manage the capital project across organizational boundaries and is responsible for its successful delivery. Ensures the project is conducted at the highest quality, within time and budget, and that the risk level and stakeholder expectations are managed. Ensures adherence to the GMS GOP - Planning and Execution of Capital Investment Projects Coordinates and supervises project execution related activities, from initiation to close out and successful hand-over. Leads a cross functional team of internal and external specialists. Responsible for meeting project scope requirements, schedule requirements, and costs. Interfaces with major projects/initiatives at the specific plant. Transfers best practices across functions and business units as well as other sites. Ensures compatibility and consistency with the existing organization and industry standards (PMM, cGMP, GEP, etc.) Coordinates with all stakeholders, facilitates problem solving sessions and or other planning sessions, and makes adjustments to the project in alignment with the overall business strategy. Responsible for the adequate utilization of all quality systems as defined by Procedures within the project organization. Ensures appropriate safety measures are taken to prevent injuries and minimizes safety risks. Ensures readiness for inspections together with quality organizations. Ensures compliance with rules and regulations of procurement and accounting. DIMENSIONS AND ASPECTS Project CAPEX Size of project: about 1000 Oku Yen Technical/Functional (Line) Expertise Knowledge of manufacturing processes and engineering documents, such as facility layouts, P&IDs, equipment arrangements, facility design, and facility costs. Knowledgeable in project management methodologies (i.e.PMBOK, PMI etc.). Awareness of current state of the art in the field of pharmaceutical engineering and biotechnology and familiarity with GMP and other regulations. Knowledgeable in project controlling and scheduling Leadership Influencing and collaboration skills. Leadership and problem solving skills. Foster a culture of collaboration, continuous improvement, and innovation among project teams. Decision-making and Autonomy Within his/her area of expertise as defined at the project start. Interaction Experience working in large company environment with matrix organizations. Experience in working and communicating globally in the pharmaceutical or biotech industry. Anticipates and resolves conflict situations in a win-win outcome. Team based player. Innovation Evaluates and proposes innovative project delivery methods where applicable. Translate innovation initiatives across into project execution and design. Complexity Must be self-motivated, have good interpersonal skills, capable of analyzing and solving complex problems through innovative thought and experience.

職務内容 医薬品製造の各プロセス(原薬、製剤、検査包装)のいずれかの技術担当者として、以下の業務を担当いただきます。 原薬プロセス：原料血漿から分画(遠心分離やろ過など)を行って薬効成分を抽出し精製するプロセス。 製剤プロセス：薬効成分を安定化するため製剤処方化し、無菌的に充填するプロセス。 検査包装プロセス：充填したバルク医薬品を検査し、ラベルを貼付して、包装するプロセス。 ・製造サポート業務(生産トラブル対応、逸脱、是正/予防措置の対応) ・改善業務(製造法改良、現場改善活動のリード、デジタル技術導入、原価低減策立案、合理化技術検討) ・査察対応業務(申請書作成、査察時の対応) ・技術移管業務(グローバル製品の国内導入の対応、新設備/プロセスのクオリフィケーションなど) ・新棟建設業務のプロセス設計支援 ・製造に関する中長期計画/プロジェクト、技術継承の計画立案／仕組みづくり ・各種トレーニング計画／教育の実施

職務内容 このポジションの主な目的は、サイト品質システム&コンプライアンスリードと協力して、パフォーマンス能力を構築し、強化し、GMSGQ内のトレーニングに関するグローバル基準へのコンプライアンスを確保するために、サイトのGxP学習システムを開発し、維持することです。 サイトのラーニングリードは、頑健なトレーニングニーズ分析に基づいてサイトのGxP学習計画を確立し、複数の部門にわたるGXP規制対象の製造環境に関する業務上のコンピテンシー要件を提供し、サイトのニーズと事業目的に基づいてGMS学習戦略を実施する責任を負います。 GMPトレーニングの監督に責任を負う品質システムの社員と協力して、サイトのニーズを満たすために効率的、効果的、適合性のある学習システムが整備されていることを保証するために、グローバルトレーニング方針及びGOP（グローバル作業手順書）の実施を監督します。関連するアプリケーション管理と展開を含む、LMS（Learning Management System）プラットフォームの継続的な展開及び使用を管理する責任を負います。 また、任命されたグローバルラーニングチームのビジネスパートナーと協力して、頑健な学習システム要素が整っていること、及びサイトが使用するための適切な技術的学習ソリューションが提供されていることを確認します。サイトの標準構造に従い、トレーニングはサイトレベルでビジネスエクセレンスに報告し、サイトにおける品質からのトレーニング品質システム要素の監督を行っていただきます。 ACCOUNTABILITIES: The core purpose of this position is to develop and maintain the site GxP Technical Learning system to build and enhance performance capability and ensure compliance with Global standards for training within GMSGQ (Global Manufacturing & Supply and Global Quality organizations) in partnership with Site Quality Systems & Compliance Lead. The Site Learning Lead is responsible for establishing the site GxP learning plan, based on robust training needs analysis to deliver the operational competency requirements for a GXP regulated, manufacturing environment across multiple functions and for implementing the GMS learning strategy based on site needs and business objectives. They oversee the implementation of global Training policies and GOPs (Global Operating Procedures) to ensure an efficient, effective, and compliant learning system is in place to meet site needs, in partnership with Quality Systems colleague with responsibility for GMP training oversight. Responsible for managing the continued deployment and use of LMS (Learning Management System) platforms, including administration and delivery applications. The Site Learning Lead works with their assigned Global Learning Team Business Partner to ensure robust Learning system elements are in place and appropriate technical learning solutions are provided for site’s use. As per the Standard Site Structure, Training reports to Business Excellence at the site level, with oversight of the Training Quality System element from Quality at site.

OBJECTIVES/PURPOSE A Computer System Validation (CSV) engineer is responsible for ensuring that computerized/automation systems used in the manufacturing, testing, and distribution of pharmaceutical products are validated and comply with regulatory requirements. The CSV engineer works closely with cross-functional teams, including manufacturing/production, IT, quality assurance, and regulatory affairs, to develop and execute validation plans, protocols, and reports. ACCOUNTABILITIES Acting as Computer Systems Validation (CSV) engineer in the Engineering workstream of the project, he/she will: Report to the CQV Lead/Validation Manager. Develop and execute validation plans, protocols, and reports for computer systems. Ensure that computer systems are compliant with regulatory requirements, including FDA regulations, GxP guidelines, and industry standards. Collaborate with cross-functional teams to identify and mitigate risks associated with computer systems. Conduct risk assessments and develop risk mitigation strategies for computer systems. Develop and maintain standard operating procedures (SOPs) for computer system validation. Provide training and guidance to end-users on the proper use of computer systems. Participate in audits and inspections to ensure compliance with regulatory requirements. Keep up-to-date with industry trends and best practices related to computer system validation. Manage vendors/contractors related to CSV activities.