Johnson & Johnson キャリア

【Janssen】富士工場 バリデーションマネジャー

富士市, 日本
Quality (Eng)


Requisition ID: 1805624012W

<Role and Responsibilities>

・Manage and improve validation / qualification activities / approach related packaging equipment / process, QC equipment and computer system in Fuji site according to lifecycle approach as a validation manager. 

・Support new product introduction by leading validation / qualification.

・Review and approve all documents related to validation / qualification.

・Create / revise the related SOPs and Validation Master Plan to comply with Japanese GMP requirements and Janssen global requirements.

・Perform risk assessment for any change items and decide all actions related to validation / qualification. 

・Provide validation / qualification training and consultation to relevant department.

・Have a responsibility for GMP audit by MHLW and Internal / Janssen Global audit related to validation / qualification. 

・Support troubleshooting of packaging equipment / process, QC equipment and computer system in Fuji site in close collaboration with Quality, engineering, production and other relevant departments.

・Build a strong relationship collaborate with Global Technical Operations and related department at Fuji site.


<Skills and Capabilities>

・Ability to operate in a diverse and ambiguous environment

・Ability to communicate in a clear, concise manner

・Ability to look at situations always from a win-win perspective

・Logical thinking and approach

・English communication skill

・Knowledge and experience of validation / qualification.



<Preferred Personality>

Open mindset, eager to learn, positive/can-do attitude, wants to change and drive improvements, ambitious and looking for future career growth in a top global company.


<Preferred Experience>

・Experience of pharmaceutical company more than 5 years.

・Knowledge and experience of pharmaceutical packaging equipment / process.

・Experience in Quality Assurance and/or Technical Services and/or Quality Control

・Greenbelt certification

Janssen Pharmaceutical K.K. (7195)
Quality (Eng)
Requisition ID