Sr. QA Specialist

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募集要項

会社概要

同社は様々な製品を提供する世界有数の医薬品、健康管理事業を行っている米国企業の日本法人です。
診断薬・機器、医薬品、病院用製品、栄養剤など多彩な製品群を持ち、診断から治療まで広範囲にカバーする高品質・高機能の製品とサービスを提供し、高い評価を得ています。もちろん部門間での異動や情報共有もされており、総合ヘルスケアメーカーとして圧倒的な地位を築いています。

業務内容

As a Sr. QA Specialist for this business unit in Japan, lead the process for the Japan organization in support of the organization’s business objectives under the GVP Manager. The role is responsible for the quality assurance process for all Medical Device and IVD products for the Japan organization. The Sr. QA Specialist will ensure full compliance with all laws, regulations, policies and standards including PMD Act, GVP Ordinance and relative Administrative Notifications. In addition, compliance with company SOPs and the development and implementation of additional local SOPs, work instructions, checklists etc., is required. Main responsibilities:

• Manage Medical Device/IVD products safety process according to legal requirements and company policies. Collaborate with Domestic Quality Assurance Manager in the Japan organization and other QA departments in the company’s Japan entity.
• Establish and drive the safety strategy for the Japan organization by taking ownership and aligning with key Global Quality strategies and direction.
• Ensure consistent application of relevant Medical Device/IVD products safety processes and systems by clearly defining relevant company and business‑unit SOPs and locally developed procedures. Adaptation of Global policies where required to execute activities appropriate to local requirements and market needs.
• Evaluate customer feedback including customer complaints and report to relevant competent authorities about Medical Device/IVD products Safety reports under local regulations.
• Elevate issues or significant events (Medical Device/IVD Products Safety issues) to the appropriate person with relevant facts and sufficient details to allow Subject Matter Experts responsible for the product safety, quality and performance to analyze, investigate and provide feedback and appropriate corrective actions.
• Close Medical Device/IVD products safety reports collaborating with Local/Area/Global Subject Matter Experts.
• Plan and execute Field Actions including Field Corrective Actions when necessary under close communication with Local/Area/Global Subject Matter Experts.
• Develop and maintain a Medical Device/IVD Products safety status report providing updates on key problem resolution initiatives.
• Escalate significant issues to Head of Quality and MAH Director about Medical Device/IVD products Safety process if applicable.
• Strong knowledge, interpretation and understanding of the practice of Japan MHLW, PMDA and Pharmaceutical Division of local government regulations building effective relationships with local regulators and agencies.
• Provide back up for QS, QA and QC tasks as needed.

応募条件

Minimum requirements:

• Medical device, Pharmaceutical or related industry experience (5 + years) in a QA/GVP/PV Role.
• Global cross-functional working experiences required.
• Strong knowledge of GVP Ordinance, PMD Act. and relative Administrative Notifications related to Medical Device/IVD product Safety.
• Native-level in Japanese, and ability to communicate fluently/effectively in spoken and written English is a must.
• Ability to develop resolution plans that take into account both project variables and potential intangible events so that success deadlines are routinely achieved.

 Preferred qualifications:

• Strong knowledge of ISO 13485, 21CFR part820 and ISO14971 is preferable.
• QA experience in Medical Device is preferable.
• Familiarity with regulations such as ISO 9000/13485, QSR
• Change management
• Experience in working with matrix organizations
• Program/project management
• Cross-functional/cross-divisional experiences
• Applicable technical knowledge/experience
• Ability to develop procedures and policies that clearly define efficient and effective processes needed to ensure compliance and resolve identified problems.
• Experience in leading and participating in cross-functional teams tasked with Medical Device/IVD product safety issues resolution

給与

700 - 900 万円

勤務地

東京