【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