Production Manager


Shizuoka
Permanent
Negotiable
Quality
PR/547871_1749001465
Production Manager

Job Title: Production Manager

Location: Fujinomiya, Japan

Job Description:

We are seeking a meticulous and experienced Production Manager to join our client in Fujinomiya. The ideal candidate will have a strong background in operations excellence, facilities management, and also knowledge of cGMP would be preferable.

Responsibilities:

  • Ensure all safety and health standards are met in the production area to meet the company's safety standards and objectives. Ensure complete adherence to all company GMPs (Good Manufacturing Practices) and SOPs (Standard Operating Procedures).
  • Part of the start-up team in the qualification, validation, operation, and optimization of the Colorcon Japan manufacturing plant in Fujinomiya, meeting established specifications, schedules, volume/cost/wastage targets, and production quality standards.
  • Continuous improvement for current production processes and procedures, proposals for improvements, implementation, and follow-through of agreed upon changes.
  • Provide leadership in departmental continuous improvement and lean initiatives.
  • Perform manager responsibilities, including interviewing, workforce planning, training, monitoring work, performance reviews, career development, discipline, and issue resolution in compliance with laws and company policies.
  • Co-work with QA/QC to prevent quality issue by CAPA (Correction Action and Preventive Action) to meet our customer requirements.
  • Participating in QMS activities includes documentation and record control, internal and external audits, and corrective and preventive actions for audit findings related to production.
  • Liaise with different stakeholders, such as Engineering, Supply and logistics, Sales, etc., as input to develop production schedules and allocate labor/capital resources.
  • To support / plan departmental expense & capex budgeting based on the forecast as per business requirements.
  • Communicate regularly with upper management regarding problems or issues impacting production.
  • Support customer complaints related to production.
  • Support the implementation of lean initiatives and continuous improvement projects within the department and company.

Requirements:

  • Bachelor's degree and at least 5 years' experience in highly regulated and GMP manufacturing industry as similar role, experience in producing pharmaceutical oral dosage form products is highly desirable.
  • Proven experience in industrial hygiene sampling, collecting, and interpreting data, recording, and tracking metrics, etc., to identify trends and appropriate next steps.
  • Equipped with knowledge of pharmaceutical current good manufacturing practices (cGMP) and modern safety program (behavior-based safety) in operation.
  • Strong verbal and written communication skills in English, and native level Japanese.
  • Ability to use computer and media technology effectively, including Outlook, MS Office (Word, Excel, PowerPoint), MS Project, Internet, and shared data networks
  • Lean & Six Sigma experience an advantage.
  • Excellent teamwork and collaboration capabilities.

Benefits:

  • One-off relocation package for those who are open to relocate

Please apply with your CV attached if you are interested!

職種: 製造マネージャー(Production Manager)
勤務地: 日本・富士宮市

職務内容:
富士宮市にあるクライアント企業にて、細部にまで注意を払い、経験豊富な製造マネージャーを募集しています。理想的な候補者は、オペレーションの卓越性、施設管理に関する強いバックグラウンドを持ち、cGMP(医薬品の製造管理および品質管理基準)に関する知識があれば尚可です。

主な業務内容:

  • 製造エリアにおける安全衛生基準を遵守し、会社の安全目標を達成する。
  • GMP(適正製造基準)およびSOP(標準作業手順書)を完全に遵守する。
  • カラーコン・ジャパン富士宮工場の立ち上げチームの一員として、設備の適格性評価、バリデーション、運用、最適化を担当し、仕様、スケジュール、生産量/コスト/廃棄物目標、生産品質基準を満たす。
  • 現行の製造プロセスおよび手順の継続的改善、改善提案、実施、合意された変更のフォローアップ。
  • 部門の継続的改善およびリーン活動におけるリーダーシップを発揮。
  • 面接、労働力計画、トレーニング、業務監督、評価、キャリア開発、懲戒、問題解決など、マネージャーとしての責任を遂行(法令および社内規定に準拠)。
  • QA/QCと連携し、CAPA(是正措置および予防措置)を通じて品質問題を未然に防止し、顧客要求を満たす。
  • QMS(品質マネジメントシステム)活動への参加(文書・記録管理、内部・外部監査、監査指摘事項への是正・予防措置など)。
  • エンジニアリング、サプライ・物流、営業などの関係者と連携し、生産スケジュールの策定および人員・資本リソースの配分を行う。
  • 事業計画に基づき、部門の経費および設備投資予算の策定・支援。
  • 生産に影響を与える問題について、上層部と定期的にコミュニケーションを取る。
  • 生産に関連する顧客クレームへの対応。
  • 部門および会社全体でのリーン活動・継続的改善プロジェクトの実施支援。

応募資格:

  • 学士号を有し、GMPが厳格に求められる製造業界での5年以上の経験(同様の職務)。経口剤製造の経験があれば尚可。
  • 産業衛生に関するサンプリング、データ収集・分析、記録・指標管理などの実績。
  • 医薬品のcGMPおよび行動ベースの安全プログラムに関する知識。
  • 英語での優れた口頭および書面でのコミュニケーション能力、日本語はネイティブレベル。
  • Outlook、MS Office(Word、Excel、PowerPoint)、MS Project、インターネット、共有データネットワークなどのITスキル。
  • リーンおよびシックスシグマの経験があれば尚可。
  • 優れたチームワークと協調性。

福利厚生:

  • 転居可能な方には一時的な引越し支援パッケージあり。

ご興味のある方は、履歴書を添えてご応募ください!

FAQs

Congratulations, we understand that taking the time to apply is a big step. When you apply, your details go directly to the consultant who is sourcing talent. Due to demand, we may not get back to all applicants that have applied. However, we always keep your CV and details on file so when we see similar roles or see skillsets that drive growth in organisations, we will always reach out to discuss opportunities.

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That's why we recommend registering your CV so you can be considered for roles that have yet to be created. 

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