Regional Quality Management (Assistant Manager)

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Job details

Company overview

Our client is the Japanese subsidiary of a world leading chemical company. It provides innovative products and solutions to a wide range of industries in Japan and internationally. Its key business areas include chemicals, plastics, agricultural solutions, performance products, and oils/ gas.

Responsibilities

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

Requirements

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

Salary

6.5 - 8 million yen

Location

Tokyo