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GCP/GVP Quality Specialist

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https://www.talent-book.jp/chugai-pharm/stories/56414

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Background of recruitment¡§
For the enhancement of QMS/QA in the GCP/GVP domain

Description of work:
Depending on suitability, you will be assigned for one of the following tasks:
­¡ QMS tasks
¡¦Formulate comprehensive QMS processes/digital strategies for GCP/GVP and promote them at a global level
¡¦Plan and execute QMS strategies in the GCP/GVP domain, evaluate their effectiveness, and continuously improve them
¡¦Keep up with the latest trends in GCP/GVP regulations and implement continuous improvement activities to strengthen QMS operations
¡¦Continuously improve QMS activities and QA governance through committees and the Global Process Owner Network
¡¦Develop plans to achieve promised results in line with team and department goals

­¢ QA tasks
¡¦Propose improvements to the Quality Management System (QMS) and review CAPA Plans based on the compliance status with domestic and international regulatory requirements and internal regulations through GCP/GVP audits
¡¦Respond to complex inquiries from regulatory authorities or partner auditors as GCP/GVP Inspection Lead
¡¦Provide consulting services based on regulatory requirements and internal regulations for complex inquiries in the GCP/GVP area

Position Features
¡¦ Deepen understanding of a wide range of QMS/QA tasks through collaboration with various Quality task personnel and utilize it for continuous improvement
¡¦ Engage in QMS/QA activities in both PV and GCP domains within the same organization, allowing for high-level activities from a GxP perspective
¡¦ Improve advanced regulatory response capabilities in Europe and the US by working in a global field
¡¦ Strengthen wide networking and communication skills through collaboration with internal and external, domestic and international customers and stakeholders 
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Desired experience¡§
¡¦Practical experience in GCP or GVP (3 years or more)
¡¦Quality management tasks (SOP maintenance, CAPA response)
¡¦Audit/inspection experience
¡¦Experience working with overseas affiliates (customers)

Desired skills/knowledge/abilities¡§
¡¦Skills and knowledge to support QMS improvement and CAPA development
¡¦Specialized knowledge for domestic and international regulations related to GCP/GVP

Desired competencies¡§
¡¦Promote constructive discussions and collaborate with members even in situations of conflict or confrontation, positively influencing other members
¡¦Respect each other's positions, listen to stakeholders' opinions, discuss openly, respond flexibly and persistently, and pursue results while gaining stakeholders' understanding
¡¦Demonstrate leadership in addressing cross-organizational issues, involving stakeholders and working as one team to solve problems
¡¦Catch up with changes in the uncertain external environment, respond appropriately without fear of change, and collaborate with relevant parties to further improve QMS

Desired Qualification¡§
¡¦TOEIC 730 points or higher/CEFR B2 level or equivalent business English skills
¡¦( if Japanese is not your native language) Japanese Language Proficiency Test N2 level or equivalent business Japanese skills
¡¦IRCA certified ISO9001 provisional auditor qualification is preferred 
ÂÔ¶ø¡¿Salary & Benefits ϫƯ¾ò·ï¤ÎÄÌÃΤÏÅŻҥե¡¥¤¥ë¤Ë¤è¤Ã¤Æ¹Ô¤¤¤Þ¤¹¡£
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The notification of working conditions will be made in an electronic file.
If you apply, please understand this point.

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Flextime system
 
¶Ð̳ÃÏ¡¿Location ËܼҡÊÅìµþÅÔÃæ±û¶è¡Ë/ Main Office (Chuo Ward, Tokyo)