募集要項
- 仕事内容
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Quality Assurance activities of the Marketing Authorization Holder as described below:
Assures Quality Assurance activities operate within established policies/procedures, global requirements, and all applicable governmental regulations.
Establishes and maintains robust local procedures to support implementation of all Quality Assurance activities as defined in the GQP regulations.
Supports the preparation, implementation, and follow-up activities relating to GQP regulatory inspections for Marketing Authorization license renewal.
Critically assess Quality Systems and their implementation to ensure procedures are followed appropriately.
Supports the generation of and tracking of CAPAs, as part of the GQP self-inspection process.
Drives proactive and continuous improvement of all GQP processes.
Performs market release of products including management of the release schedule and ensures a robust release process.
など
- 応募資格
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- 必須
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BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) required.
Must have strong knowledge of and broad experience in Quality Assurance and Quality Control activities.
Must have strong demonstrated communication skills in Japanese and English.
Must be conversant with applicable regulations governing operations.
Some level of contractual and financial awareness is preferred.
Highly motivated individual, with strong interpersonal and leadership skills.
- 雇用形態
- 正社員
- 勤務地
- 東京都,0
- 年収・給与
- 想定年収：700万円～1000万円程度（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?
