Qms & Compliance Specialist jobs at Msd in Japan

Job Description

• 開発戦略策定の補佐 （早期及び後期開発計画書への日本の臨床試験計画のインプット）
• 開発戦略に基づいた機構相談の立案や資料作成のサポート、及び照会事項に対する回答作成
• 治験実施計画書の立案及び翻訳・作成
  • ローカル試験（試験骨子から作成）
  • グローバル試験（主に翻訳）：米国本社や海外ベンダーへの説明、交渉を含む

• 同意説明文書（会社案）の作成
• 治験実施計画書に関連する資料（症例報告書、関連手順書等）の作成サポート及びレビュー
• 治験届（CTN）の添付書類作成とPMDAからの照会事項対応
• 症例の適格性確認、治験データに対するメディカルモニタリング、重篤な副作用（SAE）対応
• 治験総括報告書及び承認申請資料（CTD）臨床パートの作成 （メディカルライターと協働）及びレビュー
• 承認申請後の照会事項に対する回答作成、適合性調査対応
• 学会発表、論文作成及びそれらのサポート

• 医薬品臨床開発業務の経験（オンコロジー経験あれば尚可）
• 治験関連文書の作成経験（治験実施計画書の作成経験あれば尚可）
• 社内（国内・外）関連部門及び外部専門医との密接な協働作業のためのコミュニケーションスキル
• 英語力（TOEICスコア730点以上目安）

Current Contingent Workers apply

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

Job Description

Major Responsibilities

The successful candidate’s responsibilities will include, but not be limited, to the following:

• Maintaining and performing local process for accounting, including sales accounting, fix asset/lease accounting, etc.
• Assisting in closing process and preparing financial statements in both USGAAP and statutory.
• Dealing with internal and external audits by providing requested documents and explanations.
• Assisting in the preparation of accurate tax provision, tax returns and tax planning.
• Providing accounting & tax advice and guidance during the implementation of new business models or new software systems. Collaborating with cross-functional teams to assess the impact on financial processes, data migration, and reporting requirements, and making recommendations to ensure compliance and accuracy.

, Preferred Experience & Skills

• Strong knowledge of accounting, tax compliance, preferably experience in a corporate or public accounting environment.
• Proficiently using accounting software to enter and process financial transactions, generate reports, and maintain accurate financial records.
• Strong communication and interpersonal skills to collaborate effectively with internal and external stakeholders.
• Strong organizational skills and the ability to effectively prioritize and handle multiple tasks within demanding timelines.
• Business level of verbal and written Japanese and English

Qualifications

• Bachelor’s degree or above in Accounting or Finance. CPA or equivalent qualification

Current Contingent Workers apply

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

Job Description

【Main Responsibilities】

Supports new product launch projects and associated Quality & Compliance activities in accordance with established company policies/procedures and applicable governmental regulations:

• Supports Regulatory GMP Compliance Inspections of foreign and domestic manufacturers for New Product Applications, Partial Change Applications, and Periodic GMP inspections, including support for remediation of any GMP gaps.
• Participates in cross-functional new product launch projects to support Quality & Compliance activities.
• In collaboration with Manufacturers and Regulatory functions, manages the Conformance Review Process to evaluate compliance of site practices against the marketing authorizations.
• Establishes and maintains local procedures for above activities.

In addition, supports the following Quality Assurance activities of the Marketing Authorization Holder:

• Assures Quality Assurance activities operate within established policies/procedures, global requirements, and all applicable governmental regulations.
• Establishes and maintains robust local procedures to support implementation of all Quality Assurance activities as defined in the GQP regulations.
• Critically assess Quality Systems and their implementation to ensure procedures are followed appropriately. Supports the generation of and tracking of CAPAs, as part of the GQP self-inspection process.
• Drives proactive and continuous improvement of all GQP processes.
• Performs market release of products including management of the release schedule and ensures a robust release process.
• Ensures Quality Agreements are in place with all manufacturers and fully meets the intent and requirements of GQP.
• Coordinates and implements the GQP training program.
• Supports Computer System Validation activities relating to GQP systems.
• Ensures Quality Standard Codes for all company products are maintained as current.
• Supports coordination of any recall activities across a cross-functional team.

Qualification & Experience:

BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) preferred.

Must have strong knowledge of and experience in Quality Assurance and/or Quality Control activities. Must have strong demonstrated communication skills in Japanese and English. Must be knowledgeable of applicable regulations governing operations. Highly motivated individual, with strong interpersonal and leadership skills.

Current Contingent Workers apply

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

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

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

Job Description

・英会話力（TOEIC 730点以上もしくは同程度）

Current Contingent Workers apply

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.