募集要項
- 仕事内容
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Manage accurate and thorough complaint intake, troubleshooting, follow-ups, and investigations.
Act as a technical product subject matter expert.
Perform complaint investigations to determine root cause and resolution.
Ensure timely reporting of Adverse Events and reconciliation between complaint and Safety/Customer reports.
Support product/supplier changes, deviations, and CAPAs with technical write-ups and impact assessments.
Assist in maintaining GQP and QMS SOPs and monitor quality progress related to batch release, complaints, deviations, CAPAs, and change requests.
Participate in internal process audits and external supplier audits.
Engage in Global and local Quality projects and support officer activities and authority inspection.
- 応募資格
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- 必須
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Minimum 3 years’ experience in a similar role within the pharmaceutical or medical device industry.
Thorough knowledge of GMP, GQP, and good documentation practice.
Preferred experience in quality related complaint handling.
Desired experience with an electronic Quality Management system.
Excellent communication skills with the ability to meet tight deadlines.
Highly organized, detail-oriented, flexible, and a self-starter.
Effective team player across functions.
Proficiency in Microsoft Office Suite.
Qualification/Certificate:
Bachelor’s degree in life sciences or equivalent experience.
Language Requirement:
English: Business level
- 雇用形態
- 正社員
- 勤務地
- 東京都
- 年収・給与
- 想定年収：700万円～1100万円程度（応相談）※ご経験・スキルに応じて検討します。
- 待遇・福利厚生
- Social insurance?
- 休日休暇
- Full 2 holiday week system (Sat/Sun) national holidays, New year’s holiday, Annual Leave?
