Learning Lead, Narita Site/ 成田工場 ビジネスエクセレンス室 ラーニングリード(主席部員)

【職務内容】 光工場の新設工事ならびに改良工事における、洗浄バリデーション業務を実行します。 ・医薬品製造設備の洗浄プロセスを評価し、バリデートする責任を負います。 ・主な業務には、プロトコール作成、バリデーション作業の調整、バリデーションの実施、最終報告書の作成、最終バリデーションパッケージの作成、プロジェクト計画の作成が含まれます。 ・イニシャルバリデーションと再バリデーションの両方の責任を有します。さらに、製造上の課題の調査を行い、プロセスの改善を評価し、報告文書を作成します。 ・規制当局への文書提出、またはそれをサポートし、内部および外部の査察の際、必要に応じて利用できるように保管・管理します。 上記の業務を製造部門、エンジニアリング部門、薬事部門、品質管理部門、品質保証部門と日々連携して業務を行います。

esponsible for the following matters in Osaka Plant In collaboration with the plant management, lead the development and implementation of management systems and site procedures concerning environmental, health, safety using the ISO14001(Environment) and ISO45001(OHS) Lead EHS related compliance including waste water management Strive for sustainable global envirionment with zero-emission and carbon neutral Lead projects of Safe Initiative program, BCP, and security to formulate annual plan by closely monitoring the transition Ensure the requirements of corporate EHS and other related departments are in place Supervise / host EHS-related committees or meetings Lead EHS programs in association with Osaka plant restructuring with duties of government and neighboring affairs Elevate the capabilities of Osaka Plant organization for now and the future through the cross-functional collaboration Evaluate change proposals from the EHS aspects (for example, Safety, legal response and so on) on the change management process, as a EHS SME Ensure ethics and compliance DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise: Have theory-based systematic and practical knowledge on Environment Occupational Health and Safety for fulfillment of duties Comprehensive understanding of regionally emerging EHS legislation and experience of proactively responding to legislation changes Proven experience in auditing against EHS management systems Capability to train people in EHS&S methodologies Strong analytical skills and ability to convert informational data into action plans Strong customer service and responsiveness to others Sense of urgency and ability to achieve results Leadership: Make quick and practical decisions in case of emergency Provide leadership and direction to achieve the safety workplace vision through management commitment and employee ownership Take initiatives in EHS-related projects in Osaka Strong results orientation, leadership capabilities and overall structured way of working Decision-making and Autonomy: Set goals and processes in line with corporate EHS starategies and policies Facilitate senior level decision making in relation to people management practices Interaction: Create, develop and maintain relationships within GMSGQ Japan and with other divisions, affiliated companies, external experts and government office for prompt execution of EHS measures at Osaka Plant Strong interpersonal skills to get along with all levels of the organization Lead improvement of local, regional, and national EHS issues around the site Innovation: Develop and implement solutions by observing and referring to similar EHS issues within and outside the company Lead and engage team members for the AGILE program to drive continuous improvements and innovation Complexity: Ability to translate complex information into simple actions Extensive and pragmatic view beyond the site Coordinate EHS strategic matters with each department and affiliated companies in Osaka Plant

ACCOUNTABILITIES Manage, identify, hire, and develop a team to support commissioning and qualification of a new Plasma Manufac-turing facility. Manage continued growth, development, and retention of the team. Applies thorough understanding of risk-based CQ, cGXPs, GAMP5 and 21CFR Part 11 (as applicable), relevant SOP curriculum, routine project procedures, and other training as appropriate. Responsible for planning, scheduling, and leading commissioning and qualification assignments. Must demon-strate competent and effective planning, coordination, and organizational skills. Lead and interface with cross-functional team members (Engineering, Manufacturing, Regulatory Affairs, Quality, Supply Chain, and other technical disciplines) representing the respective commissioning and qualification ele-ments, as applicable, to develop the commissioning and qualification strategy based on concepts of risk-based CQ which includes user requirements, functional specifications, design specifications, commissioning and qualifica-tion. Emphasis is on ensuring commissioning and qualification activities meet defined timelines and budget while being in compliance with regulatory guidelines and industry standards. Guide peers in Commissioning and Qualification and Engineering Departments to use sound, statistically based Quality Engineering approaches in project, test plans and in analyses and interpretation of test results. Review documentation for accuracy and compliance to established procedures with the ability to approve or reject as appropriate. Ability to present a course of action to management and project team using both written and verbal communication tools. Assist with regulatory agency inspections, including interfacing with inspectors and corporate/division/internal auditors. Present commissioning and qualification strategy and protocols in regulatory inspections. Supervise commissioning and qualification personnel, contractors and outside vendors to meet project timelines, goals and milestones. Monitor and report commissioning and qualification costs including capital and cross-functional expenses. Perform other duties as directed by supervisor. DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise Must have vast experience, proficiency and leadership in pharmaceutical/biotech commissioning and qualification of large capital projects. which includes the writing and executing of protocols and standard operating proce-dures. Strong knowledge of GMPs, FDA and EU guidelines/requirements, is required. Must be considered a proficient Subject Matter Expert (SME) in all commissioning and qualification elements. Leadership Must have exceptional organizational skills and ability to analyze and plan and implement resolutions to technical problems, familiarity with auditing techniques, interpreting regulations and quality systems. Leadership and project management skills such as exceptional interpersonal/communication/influencing/negotiation skills/organization/prioritization. Decision-making and Autonomy Must demonstrate effectiveness in task completion, decision-making, empowerment of others, exception management, training, problem solving and team management. Interaction Must be able to work with site and global SMEs from External Partners, Engineering, Manufacturing, Quality, Regulatory and EHS in order to meet timelines, budgets and desired outcomes. Innovation Must be able to lead and implement optimization of processes within the department or the site. Complexity Must have advanced experience and proficiency in problem analysis and resolution, successful track record of analyzing complex technical problems, and demonstrates good troubleshooting and decision-making abilities.

職務内容 製造設備の導入、建設プロジェクトにおけるプロセス（生産・製造）機械の設計業務（詳細設計・予算算出・実行管理・試運転・引き渡し) 生産、研究、管理設備に関するユーザー部門への技術的サポート（導入、更新、改善） GMPに関する技術情報管理、新技術評価