|部署・役職名||IT Quality Professional, Koriyama Factory ★新幹線通勤もしくは100％リモートワーク可能★|
About the Department
Factory ensures the continuous and stable supply of high－quality pharmaceutical products. This is a newly created position at the KFA QA team which will focus on IT Quality. You will be accountable for quality assurance and quality advice accountable for IT systems in KFA while collaborating with the global team daily.
As 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.
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.
【必須（MUST）】At least 5 years of experience in working with the IT systems such as SAP, MHS or LIMS
Experience with quality standards within IT systems （validation experience is a must） and experience working at 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” and experience with general standards （GMP and ISO, specifically ISO9001 and ISO13485） are preferred
Fluent English （written and spoken） is required and basic level of Japanese or experience working in Japan is required
Driver's lincence is a must, as commuting by a car is required （non－Japanese Driver's Licence is ok）