Manager or Specialist, Vaccine DP Development / ワクチン製剤技術研究　担当者または課長代理

職務内容 製品出品計画を達成するため、原材料・製品に関する微生物学的な試験の実施、試験引継ぎ、SOP・記録書の作成および安定性調査・バリデーションなどに関する試験を行う ・GMP要件に基づく試験（原材料・製品の微生物学的試験） ・査察や監査時の対応 ・試験に関する技術・技能継承 ・公定書、申請書の試験に関連する業務 ・作業改善・効率化に関する業務 ・最新技術（迅速微生物技術等）の導入に関する業務

職務内容 保全活動、予備部品、設備稼働時間、設備・業務管理、安全対策の適切な計画と調整により、潜在的な遅延、欠陥、障害を事前に排除することにより、保全作業員の生産性と作業品質を向上させる。 校正を含むすべての保全作業の効果的かつ効率的な計画及びスケジューリング 製造・生産業務チームと保全組織との連携・調整を行う。 Improve maintenance work force productivity and work quality by eliminating in advance potential delays, defects and obstacles through proper planning and coordination of maintenance activities, spare parts, machine time, craft and labor needs, safety measures. Effective and efficient planning and scheduling of all maintenance work, including Calibrations Liaise and coordinate between the manufacturing/production operations teams and maintenance organizations

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

- 工場基幹ユーティリティ設備の基本計画、技術検討、将来計画を立案すると共に、工事実施に際して設計、取引先への製作指示、コミッショニングを行うことで設備導入を図る。 - 上記の生産設備を設置する建物ならびに建物設備の企画、立案、設計、取引先への製作指示、コミッショニング、クオリフィケーションを行い、建設プロジェクトを実施する。 - ステークホルダから要件をヒアリングの上で生産設備、用役設備のフィージビリティスタディ、コンセプトデザインの検討を行い、設備計画を取りまとめる。 - 生産設備や用役設備の中長期的な計画を策定・管理を行うことでサイト戦略を立案する。 - 品質保証に関する業務を理解して必要なドキュメントの作成、レビューを行う。