Regional Quality Management (Assistant Manager)

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募集要項

会社概要

同社は世界的な外資系化学メーカーの日本法人です。日本国内外で幅広い産業分野へ革新的な製品とソリューションを提供しており、主要な事業領域には、化学品、プラスチック、農業ソリューション、パフォーマンス製品、石油・ガスなどがあります。

業務内容

Main responsibilities:

• Quality support
  • Act as QA in BJL-GMP organization and maintain local GMP warehouse for import pharma goods.
  • Monitoring and understanding relevant laws and regulations related GMP/Quality management.
  • Support / Lead customer communication for quality related topics based on Quality Agreement in accordance with Japan Good Quality Practice (GQP) ministerial ordinance).
  • Working closely with country sales, regulatory, and Supply Chain Management to ensure quality issue is adequately manage and address.
  • Work together with governmental / provincial authorities or Industry associations when applying, interpreting and implementing regulations
  • Act as key responsible for Customer audit request on local GMP warehouse.
  • Conduct and support quality audits according to internal and external guidelines
  • Customer on-site audit include coordinate global on-site audit as a coordinator between functional unit(s), in setting up timeline, process and accompany with customer etc
  • Provide quality compliance related to computer systems implementation and upgrade projects.
  • Provide Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) support, in Quality related topics for Asia-Pacific region.
• Quality Guidelines
  • Responsible for the regional rollout, adaption & implementation of quality guidelines
  • Develop and maintain Quality Agreements (customers) and Service Level Agreements (“SLA”) with company sites and 3rd party contract manufacturers, Distributors, e.g. draft SLA and Quality Agreements with legal (“ICHQ7”)
  • To handle Non Conformance Management (“NCM”). To be engaging in EN NC community and conducting joint reviews of NCM performance (cases & response time) and counter-measures
  • To coordinate ENP/ ENN/ ENF non-conformances to ensure effective root cause analysis and the implementation of corrective actions (“CAPA”) to minimize customer impact by the reduction of repetitive complaints. Analyse NC trends and work with business partners (external & internal) to recommend / implement changes to EN business processes where required.
• Material Data & Label Management
  • Take on the role as regional contact person for SAP material master data and label topics
• Quality Community
  • Actively participate in relevant EN (such as Pharma / Nutrition Health / Aroma etc.) trade organizations to keep abreast of industry guidelines and best practices
  • Support Global EN community for qualification of regional suppliers according to the EN guidelines
  • Create communication matrix among the EN quality teams in Asia-Pacific
  • Represent the business at governmental organizations for the quality part
  • Ensure timely and accurate completion of customer questionnaires, surveys and other information requests in coordination with global teams

応募条件

Minimum requirements:

• Minimum of 4-5 years with hands-on experience in excipient testing, strong analytical and GMP background in pharma industry.
• Bachelor or Master’s degree in science, Pharmacy or related education

給与

650 - 800 万円

勤務地

東京