Job opening - Quality Assurance, Sr. Specialist - Manager：外資系製薬企業 in 東京23区 | Randstad

summary

東京23区, 東京都
¥9,000,000 - ¥12,000,000 per year, 年収900 ～ 1,200万円
permanent

job category
biotechnology & pharmaceutical

job details

社名
社名非公開

職種
安全性管理、品質保証、品質管理

業務内容 ...

Summary of Responsibilities:- Integrate and support quality regulations, including Japan Pharmaceutical Affairs Law and GQP/QMS ordinance.- Design and implement quality systems, procedures, and processes with cross-functional teams.- Analyze quality indicators and performance metrics, and communicate compliance status and risks.- Lead project teams in planning, reviewing, and approving quality documentation.- Assess and improve compliance to processes, procedures, and regulations; support quality inspections and audits.- Manage supplier qualification programs and monitor supplier performance.- Investigate quality events and develop action plans for deviations and product complaints.- Represent affiliate QA in regional, global, and cross-functional teams, and support technology transfer for new or changed products in Japan.(full list will be send after talking to the recruiter)

求められる経験
Qualifications:
•Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or
other technical/scientific area preferred.
•5+ years’ experience in quality assurance, quality oversight or relevant experience.
•Technical knowledge in as many of the following areas as possible: Quality, Regulatory, Process Sciences, Manufacturing Operations.
•Knowledge and familiarity with product, process, and both internal and external customer requirements.
•Knowledge of QA systems and GxP compliance requirements including regulations and standards affecting device, biologics and pharmaceutical products preferred.
•Experience working independently. Works well with manager guidance to complete tactical objectives while able to manage own time effectively.
•Strong oral and written communication skills needed. Proficiency in English.
•Excellent interpersonal skills.
•Strong computer skills and knowledge of enterprise systems such as TrackWise.

#LI-DNI

保険
健康保険　厚生年金保険　雇用保険,労災保険

待遇・福利厚生
退職金年金制度、育児休業制度、介護休業制度、産前産後休暇、総合福利厚生サービス、厚生会・クラブ活動補助、TOEIC受験料補助、財形貯蓄、従業員株式購入制度、団体扱い生命保険、定期健康診断、契約保養施設、永年勤続表彰、EAP（心の相談窓口）、他

休日休暇
日曜日,土曜日,祝日

給与
年収900 ～ 1,200万円

賞与
-
雇用期間
期間の定めなし

show more

社名
社名非公開

職種
安全性管理、品質保証、品質管理

業務内容
Summary of Responsibilities:- Integrate and support quality regulations, including Japan Pharmaceutical Affairs Law and GQP/QMS ordinance.- Design and implement quality systems, procedures, and processes with cross-functional teams.- Analyze quality indicators and performance metrics, and communicate compliance status and risks.- Lead project teams in planning, reviewing, and approving quality documentation.- Assess and improve compliance to processes, procedures, and regulations; support quality inspections and audits.- Manage supplier qualification programs and monitor supplier performance.- Investigate quality events and develop action plans for deviations and product complaints.- Represent affiliate QA in regional, global, and cross-functional teams, and support technology transfer for new or changed products in Japan.(full list will be send after talking to the recruiter)

求められる経験
Qualifications:
•Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or
other technical/scientific area preferred.
•5+ years’ experience in quality assurance, quality oversight or relevant experience. ...

•Technical knowledge in as many of the following areas as possible: Quality, Regulatory, Process Sciences, Manufacturing Operations.
•Knowledge and familiarity with product, process, and both internal and external customer requirements.
•Knowledge of QA systems and GxP compliance requirements including regulations and standards affecting device, biologics and pharmaceutical products preferred.
•Experience working independently. Works well with manager guidance to complete tactical objectives while able to manage own time effectively.
•Strong oral and written communication skills needed. Proficiency in English.
•Excellent interpersonal skills.
•Strong computer skills and knowledge of enterprise systems such as TrackWise.

#LI-DNI

保険
健康保険　厚生年金保険　雇用保険,労災保険

待遇・福利厚生
退職金年金制度、育児休業制度、介護休業制度、産前産後休暇、総合福利厚生サービス、厚生会・クラブ活動補助、TOEIC受験料補助、財形貯蓄、従業員株式購入制度、団体扱い生命保険、定期健康診断、契約保養施設、永年勤続表彰、EAP（心の相談窓口）、他

休日休暇
日曜日,土曜日,祝日

給与
年収900 ～ 1,200万円

賞与
-
雇用期間
期間の定めなし

show more

experience
Qualifications: •Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or ot

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show job details
senior regulatory affairs manager
- 東京23区, 東京都
- permanent
- ¥8,000,000 - ¥12,000,000 per year, 年収800 ～ 1,200万円
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posted 18 november 2024
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show job details

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