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Lilly <研究開発・メディカルアフェアーズ統括本部>信頼性保証本部 西神品質保証/担当・担当課長・課長/P1-P3/西神工場 in Seishin laboratories, Japan

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Overall Job Purpose:

  • 西神製造所における医薬品/医療機器製造工程、製品試験に関する製品品質保証業務

Job Responsibilities:

  • 新製品導入に伴うGMP対応、品質保証システムの構築、社内関係部門との調整(社内の国内、海外関連部門と協働し、GQP, GMPに基づく製造所としての品質基準、保証システムを構築)

  • 国内販売製品の製造所としての品質管理(製造および試験記録照査、逸脱、変更、バリデーション管理)

  • 品質情報及び品質不良等としての調査、報告業務

  • 製造所における監査対応業務、出荷判定業務

  • 社内の海外製造所との品質改善活動

(Business title: Associate/Sr Associate/Associate Quality Consultant-SQA)

Required Experience: (mandatory for hiring)

  • 医薬品・医療機器業界にて製造、品質試験もしくは品質保証業務経験(5年程度勤務)

  • (上位者の補助としてではなく)自身が(上記job responsibilitiesに記載された)業務をリードした経験がある

Essential Skills / license: (mandatory for hiring)

  • ネイティブレベルの日本語力

  • TOIEC800点以上、又は英語を用いた業務経験が半年以上ある方

Desirable Skills / license/ Experience:

  • 海外での就業経験もしくは日常的な英語での業務経験

  • 薬剤師資格

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Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

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At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!