QMS&Compliance Specialist

GMP コンプライアンスを遵守し、患者さんに提供する医薬品品質の確保及び安定供給を達成するために、品質保証として品質マネージメントシステム（ QMS ）の構築およびその運営管理を行っております。グローバル標準で一貫性を持った品質、コンプライアンス管理を行い、かつ日本の要求事項への対応も行うため、米国本社および海外サイトをはじめ、規制当局および他社とのコミュニケーションも多くとてもやりがいのある職務です 。

QMS の運営は欠かせないものであり、このポジションはグローバルグループの一員として、サイトの品質保証として非常に重要なキーポジションになります 。

GMP 適合性調査

CAPA管理

l必要とする資質

• l  医薬品・医療機器の製造販売業 / 製造業における品質保証、またはそれに準ずる業務経験を有す る （ 5 年以上）
• l 薬機法、 GMP 省令、 PIC / S 、 ICH 等の知識を有する
• l 薬学など理系の大学又は大学院程度の知識を有 する
• GMP オーディットの知識と経験
• l 工場内関連部署との協力関係を維持向上するための円滑なコミュニケーション能 力
• l 新たな業務や難しいと思われる業務にも積極的にチャレンジし、自ら知識と経験を高めていくことができる積極 性
• l 常に製品品質とコンプライアンスの責任部署として行動できる判断力と勇 気
• l 変化を受け入れ、それに対応していく柔軟性
• TOEIC 　 750 点以上）

l 望ましい資質

Position Overview – Basic Functions & Responsibility Essential function(s) includes, but is not limited to :

This position is critical to ensure sustainable compliance of site products and processes, procedures and systems with our Manufacturing devision requirements and regulatory requirements and expectations.

Under his / her responsibilities fall the quality oversight for

GMP Audit / Inspection and Internal Audit

Pre-Approval Inspection

CAPA　Management

Data Integrity

The incumbent interfaces with all site functions and the global Quality organization (collaboratively with Quality Assurance Manager) with regards to the above described activities.

Primary Activities Primary activities include, but are not limited to :

Establish and operational management of the Quality Management System (QMS) in order to ensure the quality and stable supply of pharmaceutical products provided to patients as Quality Assurance member in compliance with the Pharmaceuticals and medical devices Law, GMP compliance and Global Standards. Ensure that QMS Topic are delivered and maintained appropriately as a Site Topic Lead Ensure that adequate processes and procedures for Data Integrity / Document Management are in place and followed in all the functional area Conduct Walkthrough Audit at Site and lead the site for Regulatory Inspection and Customer Audit. Prepare documents for Pre-Approval Inspection and Periodic GMP Inspection. Lead and / or collaborate to implement Projects successfully as a Quality Assurance

Skills (include specific skill levels required to apply Our Company

Leadership Principles)

Current Employees apply

Current Contingent Workers apply

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status : Regular

Relocation : VISA Sponsorship :

Travel Requirements :

Flexible Work Arrangements :

Hybrid

Shift :

Valid Driving License :

Hazardous Material(s) :

Job Posting End Date :

12 / 31 / 2025

Requisition ID : R337080