職務 概要 Position Summary :

Responsible for providing execution system and its design, qualification, maintenance and administration at our Fuji Plant.

法規制の順守に関する責任 Regulatory Compliance Responsibilities:

Ø GMP/GCTP, Japanese law and regulation.

Ø IAPP

主な職務及び主な責任 Major Job Duties and Responsibilities:

Ø Responsible to provide technical support for warehouse control system and ISA95 level 1-2 system - project engineering and execution, system qualification, maintenance and system administration

Ø Understand company's standard and introduce new system of full meet quality requirement

Ø Being a project manager in Japan for global system project, which includes Japan process analysis, negotiation with global team, etc.

Ø Perform duties as Subject Matter Expert ( SME ) when assigned in accordance with TV-FRM-47456 "SME Assignment List at Fuji site"

Ø Manage current outside vendors and build good relationship

Ø System Automation

Ø Computer system Validation Job Requirements:

• Bachelor's degree or equivalent

• GMP/GCTP based thinking

Ø Execution system (system level 3 to 0)

Ø SAP knowledge is plus

Ø Business level in Japanese and English (Require business level of English and Japanese to be able to attend tele conference)

Ø Vendor management skill

Ø Stakeholder management skill

Ø Project management skill

Ø Good documentation skills for validation, maintenance, and administration records