MSD QMS & Compliance Specialist 

Japan 

735695524

Job Description

適合性調査

· 品質保証として工場全体を包括するため、関連部署との連携が必須であり、リーダーシップを発揮し、業務を積極的且つ主体的に実行する

· 工場内の関係部署やマネジメント層と良好な関係を構築し、効率的且つ効果的にプロジェクトを推進する

· 常に国内規制やメルク社グローバル基準に関する知識を深めるよう努力し、サイトの品質・コンプライアンスレベルを向上させる

· 各種のプロジェクトリードを遂行する

· 日常の業務・部門間、他社および当局とのコミュニケーションに必要な日本語力

· 英語文書の日本語訳をレビューするための英語力、及び海外ステークホルダーとのコミュニケーションに必要な英語力。（

Position Overview – Basic Functions & Responsibility

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

・Data Integrity

Primary Activities

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 LeadEnsure that adequate processes and procedures for Data Integrity/Document Management are in place and followed in all the functional areaPrepare documents for Pre-Approval Inspection and Periodic GMP Inspection.

Skills

• Degree in Pharmaceutic, Sciences, Engineering or related relevant discipline.
• Minimum of 5 years’ experience in the regulated pharmaceutical environment (pharma or medical device); preferably in a manufacturing site in quality and/or manufacturing roles.
• Knowledgeable of Japanese and global authority quality and compliance requirements eg: PMD Law, J-GMP ministerial ordinance PIC/S, ICH etc.
• Knowledgeable in Industry Best Practices for quality and compliance related topics.
• Strong collaboration and cross-functional leadership skills to drive continuous improvement and promote knowledge sharing and implementation of best practices across the site and with other Quality functions on global and local level.
• Preferably have project management skills.
• Preferably have previous experience in Supplier Management, Risk Assessment, Deviation Management in pharma or medical device environment
• Be ready to act as change agent
• Good Japanese and English communication skills

Current Contingent Workers apply

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