仕事内容:
【募集の背景 / Purpose & Scope】
・無菌医薬品製造設備の保守・保全業務を担い、医薬品の安定供給に貢献する。
・設備予算の立案や管理を行うと共に、見積もりから検収に至る一連の業者管理業務を担う。
・新製品の導入や設備の老朽化に伴い、新規設備の導入や設備の改造を行う。
- Responsible for the maintenance of sterile pharmaceutical manufacturing equipment and contribute to the stable supply of pharmaceuticals.
- Planning and managing equipment budgets, and responsible for a series of contractor management tasks from quotation to acceptance inspection.
- Purchase new equipment and Conduct equipment modification by the introduction of new products and equipment updates.
【職務の内容 / Essential Job Responsibilities】
(雇入れ直後)
・部門の実行計画に基づき、ESQDCを遵守し、設備管理及びその周辺業務を適切に実行する。
・GMPやSOPを遵守し、設備の維持や保守・保全活動を行う。
・異常、逸脱、変更管理などに対し、メンバー及び他部署と連携し的確に処理する。
・Properly promote manufacturing and related operations while adhering to ESQDC based on the department's implementation plan
・Maintaining equipment and carrying out maintenance activities in compliance with GMP and SOP
・Work with team members to appropriately handle abnormalities, deviations, change management, etc.
(変更の範囲)
会社内での全ての業務
【就業環境に関する要件 / Specific Physical or Environmental Requirements】
This position is based in Yaizu TC and will require on-site work.
求める人材:
【応募要件 / Qualifications】
<必須 / Required>
以下の経験を有していることが望ましい。
・医薬品製造所等でGMPによる製造業務又は設備管理業務の経験があること
・若しくは食品等のクリーンルーム等、衛生管理された環境での業務経験があること
・逸脱や変更管理に対応した経験があること
It is preferable that you have the following experience:
Experience in GMP manufacturing at a pharmaceutical manufacturing plant, etc.
Or experience working in a sanitary controlled environment such as a clean room for food, etc.
Experience dealing with deviations and change management
<歓迎 / Preferred>
・医薬品の技術移転、新製品の立ち上げ、製造プロセス改善などの経験
・施設管理や設備管理業務の経験
・英語に興味のある方(英語文書の作成、翻訳)
・Experience in technology transfer, new product launch, manufacturing process improvement, etc.
・Experience in facility management and equipment management
・Interested in English (creating and translating English documents)
勤務時間・曜日:
8:15~17:15(月~木)、8:15~15:30(金)、スーパーフレックス制
休暇・休日:
【休日 / Holidays】
完全週休2日制(土曜・日曜)、祝日、5月1日、夏季、年末年始
Weekends(Sat and Sun), holidays, May 1st, summer vacation, New Year holidays
【休暇 / Vacation Leave】
年次有給休暇、育児休業制度、介護休業制度 等
Annual paid leave, childcare leave system, nursing care leave system, etc.
勤務地:
【勤務地 / Location】
(雇入れ直後)
静岡県焼津市 アステラス製薬 焼津技術センター
Yaizu, Shizuoka
※焼津駅より通勤バスがございます。
(変更の範囲)
会社の定める事業場および自宅
給与:
【給与 / Salary】
①基本給:当人の経歴・技術・技能等を考慮して決定
②フレックスタイム制の場合:月間の所定労働時間を超えて勤務する時間に対して時間外勤務手当を支給
①Base salary: will be decided by the candidate's experience, skill and capability.
②When Flextime System is applied: Overtime allowance will be paid for time worked in excess of prescribed working hours.
【昇給 / Salary Raise】
有り
【賞与 / Bonus】
有り
【諸手当 / Allowance】
住宅手当、通勤手当 等
Housing allowance, Commutation allowance, etc.
待遇・福利厚生:
【福利厚生 / Welfare】
雇用保険、労災保険、厚生年金、健康保険、共済会制度、社宅制度、持株会制度、財形貯蓄制度 等
Employment Insurance, Industrial Accident Compensation Insurance, Welfare Pension Insurance, Health Insurance, Mutual Aid Association System, Company Housing System, Employee Shareholder Association System, Property Accumulation Savings System
その他:
【勤務開始日 / Start Date】
応相談
Will be decided according to the candidate's flexibility
雇用形態: 正社員
給与・報酬: 320,000円 - 420,000円 月給
平均所定労働時間(1か月当たり): 158時間
通勤の可否:
- 静岡県 焼津市 大住 (必須)
職歴:
- 医薬品の品質管理: 3年 (必須)
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