IT Quality Analyst/ITクオリティアナリスト
給与 ¥6000000 - ¥9000000 per annum
担当コンサルタント Yuki Tanabe
A leading international pharmaceutical organization is currently seeking an experienced professional with the skills necessary to join their team in Japan as an IT Quality Analyst. In this exciting position, the selected candidate will have the opportunity to make use of their bilingual Japanese/English skills as they assist with technical specifications and requirements for a major global company.
- Recommend appropriate validation approaches for operations, lab instruments and regional/local IT systems based upon experience
- Actively and independently steer project and business teams from a regulatory compliance and quality management perspective to meet company policies and government regulations
- Assist the quality management associate director in the region with setting and interpreting both top level IT and specialist quality and compliance policies and standards
- Assist the quality management associate director to maintain proactive IT and business engagement and collaboration to ensure quality management deliverables are aligned with customer expectations and IT strategies
- Represent the company’s IT quality management division on external regulatory bodies
- 5-8 years’ experience in the pharmaceutical/life sciences IT industry
- Demonstrated ability to independently provide IS quality input to validation projects
- Proven ability to interpret and communicate technical requirements in a business setting
- Knowledge of industry good practice and standards such as GAMP, GxP, ITIL, s404 Sarbanes Oxley, Risk Management, PMI
- Proficient speaking and writing skills in both English and Japanese
About the Company:
An international pharmaceutical organization, this company is one of the world’s largest biotechnology and pharmaceutical project manufacturers. With a product portfolio that combats major diseases across a variety of fields and operations in more than one hundred countries, this company continues to be relied upon by medical professionals across the globe.