募集要項
業務内容 |
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 |
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雇用形態 | 正社員 |
応募資格 |
Required: Bachelor degree, preferably in occupational health and safety, science, engineering or related field 8+ years of related experience with 3+ in a management role and 15+ in Industry Experience of ISO management Work experience of Registration, EHS and Regulatory affair in global company Knowledge for Industrial hygiene, industrial toxicology, industrial relation and overall of OSH Strong skills in problem finding and solving, and project management Strong leadership. Good written and verbal communication skills both in Japanese and English Strong verbal, written and presentation skills Preferred: Master of Science in Industrial Hygiene 5+ years of experience in managing safety, health, and environment issues and conducting accident investigations National certification regarding EHS matter |
英語力 | ビジネスレベル |
年収 | 1300万 〜 1700万円 |
給与詳細 | 1300万円-1700万円 |
勤務地 | 大阪府 |
備考 |
”Better Health for People, Brighter Future for the World” is the purpose of a company.We aim to create a diverse and inclusiveorganization where people can thrive, grow and realize their own potential while enabling our purpose. We continue to innovate and drive changes that will transformthe lives of patients. We’re looking for like-minded professionals to join us. global values-based, R&D-driven biopharmaceutical leader. We are guided by our values of ism, whichhas been passed down since the company’s founding. ismincorporatesIntegrity, Fairness, Honesty, and Perseverance, with Integrity at the core. They are brought to life through actions based on Patient-Trust-Reputation-Business, in this order. |
企業情報
匿名
関連する求人
【主な業務内容】 • 社内ソフトウェアアプリケーションのサポート • 以下の技術専門分野における小規模ソリューションプロジェクトの技術標準分析、実装、評価に参加および実行 — エンドユーザーサポート — ハードウェアのトラブルシューティングと故障対応 — オペレーティングシステム・ソフトウェアのサポート — ハードウェア・ソフトウェアツールとITILプロセスに沿った運用 【詳細な業務内容】 • 問題の調査、解決策の分析、小規模なプロジェクトの技術的な変更の実装など • 要件、整備、テスト、問題、アプリケーション統合などの分析 • ガイドラインやポリシーに沿った意思決定のサポート、またはチームメンバーに対してのサポートに関する意思決定の支援 • 技術的な分析・設計・変更・ソフトウェア設定・ハードウェアの解決支援を標準に沿って実行 • 通常業務内やプロジェクト内でのアプリケーションの開発サービスやテクニカルサポートの提供 • ビジネスソリューションの本番環境への展開サポート、エンドユーザー機器のライフサイクルプロセスとIT資産管理 • 社内ITインフラストラクチャとエンドユーザー機器の対面式サポートの実施 • 会議室や会議イベントのサポート • システム改善策の実装支援 • 品質マネジメントシステム(QMS)、ソフトウェア開発ライフサイクル(SDLC)、およびITプロジェクトライフサイクル(ITPLC)の標準、ポリシー、および手順に従ったサポートドキュメントの作成・維持 • マネージャ・リーダーからの指導と指示の下での業務遂行 • 主要なITおよびビジネスの目的/目標を理解し、自己知識を独自の作業分野で活用 【関連業務】 • 計画された取り組みに対する定期的な更新と、テクノロジー運用とプロジェクトに関するレポートの提供 • 管理業務のデータ精度を確保
- 500万〜800万
- 大阪府
- 医薬品メーカー(先発医薬品)
募集中
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.
- 500万〜800万
- 大阪府
- 医薬品メーカー(先発医薬品)
募集中
OBJECTIVES/PURPOSE Coordinating the engineering activities of about 1000 Oku Yen investment at the Osaka Site, Japan, to implement an end to end manufacturing facility for Plasma Derived Therapy products including Drug Substance (DS), Drug Products (DP), Inspection and Packaging (I&P) and a Cold warehouse. 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.
- 1300万〜1700万
- 大阪府
- 医薬品メーカー(先発医薬品)
募集中
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
- 900万〜1300万
- 千葉県
- 医薬品メーカー(先発医薬品)
募集中