Sr Validation Subject Matter Expert- Computer Systems Validation, Japan New Plasma Facility Project
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勤務地大阪府
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職種その他製剤化/製造・生産関連職
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業種医薬品メーカー(先発医薬品)
募集要項
業務内容 |
OBJECTIVES/PURPOSE A Computer System Validation (CSV) engineer is responsible for ensuring that computerized/automation systems used in the manufacturing, testing, and distribution of pharmaceutical products are validated and comply with regulatory requirements. The CSV engineer works closely with cross-functional teams, including manufacturing/production, IT, quality assurance, and regulatory affairs, to develop and execute validation plans, protocols, and reports. ACCOUNTABILITIES 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. |
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雇用形態 | 正社員 |
応募資格 |
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: BA or BS degree preferably in the engineering or science field. 5+ years of validation experience for non mgr role. Experience in validation of GMP manufacturing process control systems (e.g. Allen-Bradley PLC, Delta V, BAS, Siemens) Experience in control systems validation as part of a large capital project (e.g. new facility installation) is a plus. Experience in Plasma manufacturing is a plus. Prior experience in use of KNEAT (paperless validation system) in a validation project is a plus. Prior experience interacting with the FDA and other regulatory agencies. Excellent verbal and written communication skills in English and Japanese. What can offer you: Allowances: Commutation, Housing, Overtime Work etc. Salary Increase: Annually Bonus Payment: Twice a year Working Hours: Headquarters (Osaka/ Tokyo) 9:00-17:30, Production Sites (Osaka/Yamaguchi) 8:00-16:45, (Narita) 8:45-17:15, Research Site (Kanagawa) 9:00-17:45 Holidays: Saturdays, Sundays, National Holidays, May Day, Year-End Holidays etc. (approx. 123 days in a year) Paid Leaves: Annual Paid Leave, Special Paid Leave, Sick Leave, Family Support Leave, Maternity Leave, Childcare Leave, Family Nursing Leave. Flexible Work Styles: Flextime, Telework Click here to find out Diversity, Equity & Inclusion Better Health, Brighter Future |
英語力 | ビジネスレベル |
年収 | 500万 〜 800万円 |
給与詳細 |
月額(基本給):310,000円~ <昇給有無>有 <残業手当>有 <給与補足> ※年収は前職の経験を考慮の上、規定により決定します。 ■昇給:原則年1回 ■賞与:年2回 |
勤務地 | 大阪府 |
備考 |
”Better Health for People, Brighter Future for the World” is the purpose of a company.We aim to create a diverse and inclusiveorganization where people can thrive, grow and realize their own potential while enabling our purpose. We continue to innovate and drive changes that will transformthe lives of patients. We’re looking for like-minded professionals to join us. global values-based, R&D-driven biopharmaceutical leader. We are guided by our values of ism, whichhas been passed down since the company’s founding. ismincorporatesIntegrity, Fairness, Honesty, and Perseverance, with Integrity at the core. They are brought to life through actions based on Patient-Trust-Reputation-Business, in this order. |
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