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ソフトウェア検証コンサルタント/Computerized Software Validation Consultant
| Location | Tokyo - 23 Wards |
| Job Type | Contract |
| Salary | 8 million yen ~ 10 million yen |
Job Description
- Experience using Kneat, HP ALM, Kneat, SNOW as tools.
- OT systems qualification (Radioligand therapy or critical forms preferred)
- PAS/DCS Qualification
- Understanding ISA95
- OT security a plus
- Standalone System Entitlements
- PAS/DCS qualification integrated with manufacturing equipment.
- Candidate must be having user friendly experience with Kneat, HP ALM, Kneat and SNOW as tool
- OT System Qualification (Radio ligand therapy or critical dosage forms will be a plus)
- PAS/DCS Qualification
- ISA95 understanding
- OT Security will be a plus.
- Standalone Systems Qualifications
- PAS/DCS Integrated with Manufacturing Equipment qualification.
General Requirements
| Minimum Experience Level | Over 3 years |
| Career Level | Mid Career |
| Minimum English Level | Business Level |
| Minimum Japanese Level | Business Level |
| Minimum Education Level | Bachelor's Degree |
| Visa Status | Permission to work in Japan required |
Required Skills
Qualifications
- More than 10 years of professional experience and advanced knowledge based on practical experience in the above fields
- IT Quality and Compliance, Computer System Validation/Software Testing/System Implementation in the Life Sciences Industry.
- Familiar with manufacturing, quality and engineering systems and their validation.
- Excellent practitioner in stakeholder management and necessary communications
- Pharmaceutical/Life Sciences Field Knowledge
- Experience with MES, QMS (Trackwise), Lab Solutions (LIMS, Empower CDS, Chromeleon, Business Analytics, Middleware, etc.) is a plus.
- At least X years of work experience 10 years or more
Japanese: Business level Japanese, business level English.
Qualification:
- 10_ yrs. of Professional experience and strong knowledge with real time experience in areas stated above
- IT Quality & Compliance, Computer System Validation / Software Testing / System Implementation in the Life Sciences industry.
- Well versed with Manufacturing, Quality and engineering system and their validations
- Stakeholder management and good executor with required communication.
- Knowledge of Pharmaceutical / Life Sciences as domain.
- Experience to MES, QMS (Trackwise), Lab solutions ie LIMS, Empower CDS, Chromeleon, Business Analytics, Middle ware etc. will be an advantage
- Min X+ years hands on experience. 10 Years
Japanese Language: Business level Japanese required and business level English required.
Job Location
- Tokyo - 23 Wards
Work Conditions
| Job Type | Contract |
| Salary | 8 million yen ~ 10 million yen |
| Industry | IT Consulting |
Job Category
- Customer Service, Secretary and Administration > Call Center SV, Leader, Manager
- Customer Service, Secretary and Administration > Customer Service, Customer Success
- IT, Web and Communication > IT Consultant
