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Job Function:
Supply Chain ManufacturingJob Sub Function:
Manufacturing AssemblyJob Category:
ProfessionalAll Job Posting Locations:
Sunto, Shizuoka, JapanJob Description:
職務概要Position Summary:
- 正しい手順で時間通りに検査、製造する作業のオペレーション業務をリードし、正しい品質の製品を継続的に製造する。
Execute operations of inspection/production lines complying with the proper procedures on a timely manner and produce good quality products continuously
法規制の順守に関する責 Regulatory Compliance Responsibilities:
- 全ての従業員はコンプライアンスの順守を最優先にしなくてはならない。
All employees must concern compliance as high priority
- 法規、GMP及びすべての社則・サイトポリシー・手順に準じなくてはならない。
Comply with Regulation, GMP, and all company/site policies/procedures.
主な職務及び主な責任 Major Job Duties and Responsibilities:
- 責任分野におけるオペレーションに精通する。
Have knowledge and understanding in the operations of his/her responsible area - 富士工場での職務規則や作業標準を順守しながら、昼勤/夜勤の複数シフト体制の中で、医薬品の検査・包装作業の各ラインでの製造スケジュール管理を行う。
Complying with the job rules and SOPs/WIs, control production schedule on each inspection/packaging line of drug products in the multiple shifts (day/night). - 検査・包装作業を各ラインでリードし、作業の安全性、品質に関して責任を持つ
Take the lead in inspection/packaging operation on each line and take responsibilities in operational safety and product quality - ライン作業中にはシニアスーパーバイザー、スーパーバイザー、マネジャーの指示に従い、作業効率を上げる努力を行う。
Follow instructions of Supervisor/Manager during line operations and make efforts to improve operation efficiency. - 作業効率及びOEEを上げる為、関係部署と協働する。
Collaborate with other department to improve work flow efficiency and OEE.
- 検査包装作業改善提案活動、安全作業改善提案活動をリードする
Lead the Kaizen-proposal activity for inspection/packaging and for safety operations - GMP遵守のため、各種決められたトレーニングを期日までに完了する。
Complete each training by due date to be compliant to GMP requirements. - 生産中に起こった品質、コンプライアンス問題を速やかにSSV/SV、マネージャーに報告し、関係部門との折衝をリードする。
Escalate Quality and Compliance issue to SSV/SV/Manager and lead communication with related department.
- 作業逸脱、品質問題が起こった場合にはQIを起票し、QIのクローズまで責任を持ちその再発防止に努める
When any deviation or a quality issue occurred, raise a QI and take its responsibility until its closure to prevent recurrence
- 自身のエリアに関連するCPAをリードし、期限内にクローズする。
Lead a CPA in your own area and close on time.
- JJPS/JJOSに参加し、プロジェクトをリードする
Lead a project by following JJPR/JJOS process - 担当ラインの従業員及び作業場所の安全確保のリードを行う(例:LOTOTO実施の確認等)。
Take the lead in securing the safety of operators/the lines he/she owns (confirmation of LOTOTO execution)
教育/経験Education and Experiences:
- 高等学校卒業、もしくは同等の資格を有すること。
High school diploma or equivalent
知識、資格、及び技能 Knowledge, Qualification and Skills:
- データインテグリティ
Data Integrity
- ビジネスレベルの英語読解力があればなおよい(マストではない)
Business level English reading
- MS PowerPoint
- イエローベルト
Yellow belt
行動特性Core Competencies:
- コラボレーションとチームワーク
Collaboration skills and teamwork-oriented mindset
- 誠実なクレドバリュー
Credo value of integrity
- 顧客重視
Customer-focused mindset
- EHSルール及び手順の遵守
Comply with EHS rules and procedures at all times.
- 担当ラインの EHSコンプライアンス遵守・EHS文化の構築・担当ラインのリスク管理・継続的な改善の実施のリード
Take the lead in EHS compliance and EHS culture establishment on the lines he/she owns
Take the lead in risk management and continuous improvements on the lines he/she owns
- インシデント、ニアミス等の報告
Report all incidents, accident, and near miss events.
その他 Others:
- 視力(矯正可)が0.7以上であること。
Corrected eyesight is equal to or more than 0.7
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