Sales Quality Manager

勤務地 東京都
Discipline Life Science, Sales
Job type Permanent
給料 negotiatable
Reference 36404

【JOB RESPONSIBILITIES】

  • Contribute to management of Quality Assurance in Japan

  • Coordinate Quality Assurance activities  GMP/GDP : Procedure Management, Deviation & CAPA management, Complaint Management, Product Quality Review, Third Party Audit, Analytical and third party logistics subcontractor management

  • Work using: Phenix E&C and QTP, GEODE+.

  • Management of GMP/GDP at Japan DC center and Japan Head office

  • Manage QAA contracts (global and local) between Marketing Authorization Holders Japan.

  • Perform audit service providers and external API suppliers to ensue management of the services and supplies.

  • Contributes to the Change Control process at API sites for quality assessment.

  • Role of key interlocutor of the Japan Health Authority

  • Manage customer quality related requests.

【REQUIREMENTS】

  • Experience: 5-10 years in the pharmaceutical industry.

  • Core competencies: Background in active ingredient / drug product production.

  • Pharmacist License

  • English Speaking / intermediate or Fluent

  • GMP expertise