Contract manufacturing business of soft capsules for pharmaceuticals and health foods
This position is responsible for providing support to Director and cooperate with other managers (QA/QC operation, QA system) to supervise and manage tasks within Quality Assurance and Quality Control teams.
This position is based in Kakegawa in Shizuoka prefecture, Japan.
The Reporting Relationship:
This position will report to Quality Director in Kakegawa Site.
* Establish and improve the quality control system
* CAPA progress management associated with quality control
* Standard management (raw materials, IPC, products)
* Manage and supervise analytical works regarding validation
* Supplier management for raw material suppliers (audit)
* Accommodate authority and customer audits
* Promote Self-checks (internal audits, QA patrols)
* Promote CAPA
* Recall (mock recall)
* Promote Annual Performance Review (APR)
* Manage quality information (complaints)
* Responsible for closing agreements (GOP, raw material suppliers, manufacturers) and regular maintenance
* Negotiate with domestic and international manufacturers/suppliers
* Manage Pharmaceutical business authorization (acquisition/change management/maintenance of various licenses including Pharmaceutical manufacturing business license, Foreign Manufacturer Accreditation(FMA), GMP for food products, Halal, HACCP, FSC22000)
* Participate in New Product Introduction (NPI) activities
* Compliance work related to Quality team