engineer - バリデーションスタッフ/マネジャー validation staff/manager: 外資系大手製薬メーカー(600~1,200万円) in 静岡県

posted
job type
正社員
salary
¥ 6,000,000 年棒
apply now

job details

posted
location
静岡県
job category
流通・小売
job type
正社員
salary
¥ 6,000,000 年棒
reference number
54365-22
apply now

job description

社名
社名非公開

職種
サプライチェーン・マネジメント

業務内容
<Role and Responsibilities>

 



・Manage and improve validation / qualification activities / approach related packaging equipment / process, QC equipment and computer system in *** 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 *** 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 / *** Global audit related to validation / qualification. 

・Support troubleshooting of packaging equipment / process, QC equipment and computer system in *** 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 *** site

 





求められる経験
・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.


給与
年収600 ~ 1200万円