Vender Quality Management

Job Details

<求人タイトル>

19026 Vender Quality Management

<職務内容>

・Implement the QA review of deviation notifications and change controls, retrieving and collecting supportive information from involved stakeholders to allow assessment.
・Manage the KPI metrics for key operational QA activities and services associated with the vendors
・Act as the central QA point of contact for the organization for investigations/deviations/
out-of-specifications/ audit observations associated with the assigned vendors.
・Confirm all Quality agreements are in place and take ownership of agreements for the
vendors.
・Ensure the Annual Product Stability Program is rolled-out and executed at the vendor in accordance with the Stability Program
・Ensure the Product Quality Reviews (PQR) are completed by the vendors in a timely manner and as needed, are reviewed within the requested time period.
・Join as QA representative to the recurrent vendor meetings, present issues and resolutions, and drive vendor quality performance through these meetings
・Monitor and trend vendor performance including tracking of CAPA events and closure
・Act as the contact person for the follow-up with vendors for the manufacturing investigation part. Ensure that initial receipt, logging of quality complaints into the Complaint System and provision of responses to the complainant are professionally coordinated and managed.
・Work with the Vendor team and Global Quality Lead to determine the Root cause of issues which may lead to a Technical meeting. Coordinate vendor quality related investigations
・Join on ad-hoc basis to the Product Change Control Committees for activities related to the vendors and review change controls as QA stakeholder.
・Offer expert QA advice, support and management for technical operational QA and general QA matters associated with the vendors
・Collaborate with Corporate QA teams, Technical Operation Teams, Business stakeholders and Affiliates in an effective and efficient way
・Cover the entire product life cycle from initial commercialization to phase out for the assigned vendors
・Own the QA plans and product resource and capacity overview for activities associated with the assigned vendors
・Ensure all relevant documentation are provided to the vendors and implemented
・Ensure review of relevant RA dossier section related to the assigned vendors
・Overview the company’s audit and HA inspections related to the vendors.
・Act as the QA stakeholder for Vendor Risk management .
・Manage and control quality documents related to the vendors
・Provide support to customer audits and Health Authority inspections at the vendors
・Receive, coordinate, review and authorize product reworks and repackaging
・Act as the point of contact for post-release vendor quality issues

<応募要件>

・5~10 years working experience in pharmaceutical Industry (production, QA or QC)
・Understand several areas of the global pharmaceutical industry, including the interpretation and practical application of applicable regulations.
・Deep knowledge of the pharmaceutical industry from a business and technical perspective including manufacturing of sterile products.
・Experienced in interaction with regulatory bodies and third-party organizations with respect to QA systems and regulatory inspection preparedness
・Experience in conducting customer / vendor audits and participation in the management of
regulatory inspections
・Able to act in most circumstances without direct supervision and handle complex/difficult situations
・Able to effectively interact with and influence senior internal and external personnel on many aspects of project and product related matters
・Possess excellent interpersonal, verbal, and written communication skills at all levels internally and externally especially at senior management levels
・Able to fluently communicate in English and Japanese language (reading, writing,
speaking, comprehension when listening)
・Skilled and experienced in operating across cultures and in a multi-cultural environment
・Root cause and risk management/assessment skills

<会社概要>

免疫炎症・神経疾患などの領域を中心に、革新的な医薬品の研究開発、ソリューションの提供に力を注いでいるグローバルバイオファーマです。

就業時間:フレックスタイム制 (フレキシブルタイム6:00~22:00、コアタイム無し、一日当たりの所定労働時間は7時間30分)

<注目ポイント>

今後非常に成長が見込めるグローバルバイオファーマよりベンダーマネジメントポジションのご紹介です!ダイバーシティのある環境で、ワークライフバランスの充実にも取り組んでいる企業です。日本人のコンサルタントでご相談可能ですので、ご興味がございましたら是非お気軽にお問い合わせください!!

Job application

Apex delivers strong profile and highly skilled candidates that match the job description requirements. Their candidate know how, network and experience helped us to initiate contact and integrate the candidate into our company. We are very happy with the candidate selected by Apex. K.K. consulting service. Thank you for the professional recruitment consulting service throughout the selection and follow up. We really appreciated it and strongly recommend Apex.

APAC Head of Supply Chain

Global Healthcare Company