社名
社名非公開
職種
社内SE、情報システム
業務内容
...
The PositionAs the only IT Quality Professional of the Quality Assurance (QA) team, you will be accountable to assist and provide advice on initiatives related to IT system qualification and compliance. Participate and contribute to audit and inspections as IT and Quality advisor. Guide Process Confirmations along with existing quality assurance oversight activity and participate in relevant cross functional initiatives and projects relating to IT systems.Other role tasks are as follows, but are not limited to:- As IT QA for system, you will handle and approve deviations and change requests related to IT systems. Identify compliance issues and take initiative to having them closed timely, as well as give input and guidance in relations to quality evaluations and other quality ensuring tasks.- Contribute to validation planning, including IT risk management and conclusion of appropriate validation strategy. Review and approve key deliverables according to validation planning. You will also establish and maintain quality oversight related to the system or services to ensure compliance with internal and external requirements in collaboration with IT System Owner.- Assist SOP (Standard Operating Procedures) content accountable to remove unnecessary complexity in process and IT related documents. Partner with Quality to drive initiatives to improve IT qualification and maintenance practices in the company.- Preparation of documentation related to IT systems and presentation in audit and inspections. Participate in follow up of findings and development of action plans when related to IT systems.- Represent Quality in relevant projects and contribute to finding the right solutions. Provide Quality and IT expertise during projects in Koriyama Factory. Ensure excellent collaboration within stakeholders in the organisation and participate as QA in digitalization projects both in KFA and in global.
求められる経験
Qualifications
- At least 5 years of experience working with IT systems such as SAP, MHS or LIMS.
- Experience with quality standards within IT systems (validation experience is a must) and experience working at a factory.
- Knowledge of Japanese IT requirement “コンピュータ化システム適正管理ガイドライン”.
- Experience with general standards (GMP and ISO, specifically ISO9001 and ISO13485) are preferred
- Fluency in English (written and spoken), and basic level of Japanese, or experience working in Japan, are required.
- Driver's licence is a must, as commuting by a car is required (non-Japanese Driver's Licence is acceptable).
保険
健康保険,厚生年金保険,介護保険,雇用保険,労災保険
休日休暇
日曜日,土曜日,祝日
給与
年収500 ~ 800万円
賞与
-
show more
社名
社名非公開
職種
社内SE、情報システム
業務内容
The PositionAs the only IT Quality Professional of the Quality Assurance (QA) team, you will be accountable to assist and provide advice on initiatives related to IT system qualification and compliance. Participate and contribute to audit and inspections as IT and Quality advisor. Guide Process Confirmations along with existing quality assurance oversight activity and participate in relevant cross functional initiatives and projects relating to IT systems.Other role tasks are as follows, but are not limited to:- As IT QA for system, you will handle and approve deviations and change requests related to IT systems. Identify compliance issues and take initiative to having them closed timely, as well as give input and guidance in relations to quality evaluations and other quality ensuring tasks.- Contribute to validation planning, including IT risk management and conclusion of appropriate validation strategy. Review and approve key deliverables according to validation planning. You will also establish and maintain quality oversight related to the system or services to ensure compliance with internal and external requirements in collaboration with IT System Owner.- Assist SOP (Standard Operating Procedures) content accountable to remove unnecessary complexity in process and IT related documents. Partner with Quality to drive initiatives to improve IT qualification and maintenance practices in the company.- Preparation of documentation related to IT systems and presentation in audit and inspections. Participate in follow up of findings and development of action plans when related to IT systems.- Represent Quality in relevant projects and contribute to finding the right solutions. Provide Quality and IT expertise during projects in Koriyama Factory. Ensure excellent collaboration within stakeholders in the organisation and participate as QA in digitalization projects both in KFA and in global.
...
求められる経験
Qualifications
- At least 5 years of experience working with IT systems such as SAP, MHS or LIMS.
- Experience with quality standards within IT systems (validation experience is a must) and experience working at a factory.
- Knowledge of Japanese IT requirement “コンピュータ化システム適正管理ガイドライン”.
- Experience with general standards (GMP and ISO, specifically ISO9001 and ISO13485) are preferred
- Fluency in English (written and spoken), and basic level of Japanese, or experience working in Japan, are required.
- Driver's licence is a must, as commuting by a car is required (non-Japanese Driver's Licence is acceptable).
保険
健康保険,厚生年金保険,介護保険,雇用保険,労災保険
休日休暇
日曜日,土曜日,祝日
給与
年収500 ~ 800万円
賞与
-
show more