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Hiring Company | 武田薬品工業株式会社 |
Location | Osaka Prefecture |
Job Type | Permanent Full-time |
Salary | 5.5 million yen ~ 11 million yen |
【求人No NJB2207746】
Acting as Computer Systems Validation (CSV) engineer in the Engineering workstream of the project he/she will:
■Report to the CQV Lead/Validation Manager.
■Develop and execute validation plans protocols and reports for computer systems.
■Ensure that computer systems are compliant with regulatory requirements including FDA regulations GxP guidelines and industry standards.
■Collaborate with cross functional teams to identify and mitigate risks associated with computer systems.
■Conduct risk assessments and develop risk mitigation strategies for computer systems.
■Develop and maintain standard operating procedures (SOPs) for computer system validation.
■Provide training and guidance to end users on the proper use of computer systems.
■Participate in audits and inspections to ensure compliance with regulatory requirements.
■Keep up to date with industry trends and best practices related to computer system validation.
■Manage vendors/contractors related to CSV activities.
Minimum Experience Level | No experience |
Career Level | Mid Career |
Minimum English Level | Daily Conversation |
Minimum Japanese Level | Native |
Minimum Education Level | Technical/Vocational College |
Visa Status | Permission to work in Japan required |
Job Type | Permanent Full-time |
Salary | 5.5 million yen ~ 11 million yen |
Work Hours | 08:00 ~ 16:45 |
Holidays | 【有給休暇】初年度 12日 1か月目から 完全週休二日制(土・日)、祝日、メーデー、年末年始、他 特別有給休暇、リフレッシュ休… |
Industry | Pharmaceutical |