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