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MSAT （Manufacturing Science ＆ Technology） Senior Manager
年収：900万 ～ 1600万
採用企業案件
ヤンセンファーマ株式会社
-
- 会社規模501-5000人
- 医薬品メーカー
| 部署・役職名 | MSAT （Manufacturing Science ＆ Technology） Senior Manager |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
1. The launch of new technology, products and technical transfers. 2. The validation process and execution (Process and Cleaning Validation). This includes lifecycle management of products (including continuous improvement). 3. Packaging engineering – including the management of packaging specification for new and current packaging material (primary, secondary and tertiary). Also includes artwork management. 法規制の順守に関する責任 Regulatory Compliance Responsibilities: 1. Good Manufacturing Practices (GxP) l Adhere to applicable cGxP’s and procedures & local Japanese regulatory requirements. l Report incidents and deviations l Propose solution to improve compliance with cGMP’s 2. Safety, Health and Environment Performance l Adhere to applicable EH&S and procedures (role model). l Correct use of the available personal and protective equipment. l Reporting of good saves, accidents, incidents, deviations. l Cooperate on and suggest solutions to improve EH&S. l Actively promote EH&S, support campaigns/programs such as “Safe behavior”. 主な職務及び主な責任 Major Job Duties and Responsibilities: Manage Product Transfer /Product Introduction for the Site l Manage the NPI Manager to ensure: Ø Products are launched on time and in full. Ø NPI projects followed the necessary standards. Ø NPI projects are achieving plans on target. Where gaps/challenges exist provide the necessary support to the team to overcome these challenges. Ø Manage NPI stakeholders together with NPI manager to ensure issues are escalated appropriately and that the team is well supported. l Work with Regional, Global and Local leadership teams to set the vision for the site’s and region’s technology roadmap. l Develop the NPI team through regular performance and career conversations. Validation Processes and lifecycle management l Manage the Validation (group) Manager to ensure: Validation processes are followed as per standards, including the maintenance of the Validation Master Plan. l Lead or support complex failure investigations (escalation of quality or compliance events). Packaging Engineering l Manage the packaging engineers/packaging SMEs to ensure: Ø Evaluate and implement packaging solutions to meet local market requirements. Ø Correct management of materials against the standard. Ø Packaging Innovation and new technology introduction. Inspection Readiness and Execution l Technical support in partnership with Quality on any regulatory audits and inspections l Support through the TO team organization audits including preparing and delivering presentations, explanations, etc. Organizational Leadership l Accountable for managing team in accordance to Site and Technical Operations priorities following the JSC Business Cascade (Budgeting, Resources) l Motivates and inspires site team to drive significantly increased performance through technical innovation and change. Provides leadership and development to the team and ensures there is a diverse pipeline of high performing multi-skilled leaders of the future. |
| 応募資格 |
【必須（MUST）】 教育/経験Education and Experiences: (Essential)1. University degree in Engineering or Science 2. Project management experience 教育/経験Education and Experiences: (Desirable) 1. Master Degree or Equivalent 2. FPX (Flawless Project Execution) program experience 知識、資格、及び技能 Knowledge, Qualification and Skills: 1. Formulation (Desirable), Primary Packaging and Secondary Packaging 2. API Manufacturing for small/large molecules (Desirable). 3. Quality Assurance and Regulatory 4. Strong Ability to operate in a diverse and ambiguous environment. 5. Ability to think strategically. 6. Ability to look for win-win situations. 7. Fluent in English. 8. Fluent in Local Language ( Desirable) |
| 受動喫煙対策 | その他 「就業場所が屋外である」、「就業場所によって対策内容が異なる」、「対策内容は採用時までに通知する」 などの場合がその他となります。面接時に詳しい内容をご確認ください |
| 更新日 | 2024/05/29 |
| 求人番号 | 3568553 |
採用企業情報
- ヤンセンファーマ株式会社
-
- 会社規模501-5000人
- 医薬品メーカー
-
会社概要
私たちヤンセンファーマは、世界最大級のトータル・ヘルスケア・カンパニー、
ジョンソン・エンド・ジョンソン（J＆J）グループの製薬会社として、いまだ
満たされていない医療ニーズに迅速に応え、最先端の医薬品を一刻も早く患者
さんの手元に届けることができるよう取り組んでいます。
私たちは、世界57ケ国200社以上に及ぶJ＆Jグループを貫く経営理念「我が信条
（Our Credo）」を志とし、さらに、46年間に84品目もの新薬を開発したヤンセ
ン・ファーマスーティカ社の創業者、ポール・ヤンセン博士の妥協なき開発精
神を継承し、J＆Jグループの優れた新薬の導入はもちろん、医療現場への適切
かつ最新の医療情報の提供、さらには、患者さんのＱＯＬ（クオリティ・オブ・
ライフ）の向上を目指した支援活動などをおこなっています。
転職・求人情報の詳細をご覧になる場合は会員登録（無料）が必要です