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About the Role

As an expert in quality control within the pharmaceutical industry, this position leads compliance with regulatory requirements and audit responses. The role focuses on improving the efficiency and quality of pharmaceutical manufacturing processes and contributing to the maintenance of quality management systems compliant with GMP standards.

Responsibilities

• Support and implement response plans for internal and external audits.
• Evaluate and propose improvements for the quality management system.
• Create and implement Standard Operating Procedures (SOPs) based on regulatory requirements.
• Conduct GMP risk assessments and optimize quality control processes.
• Collaborate with client quality control departments to resolve issues and drive continuous improvement activities.
• Create regional/site SOPs and templates as needed.
• Conduct risk assessments for maintenance/calibration.
• Obtain permits for maintenance/calibration/projects.
• Assess quality impact and release after maintenance.
• Archive maintenance documentation.
• Execute change requests.
• Investigate deviations (root cause analysis).
• Conduct project risk assessments.
• Prepare equipment specifications and system requirements for projects (e.g., User Requirement Specifications).
• Prepare functional specifications for projects.
• Execute project work instructions according to Method Statements.
• Conduct GMP risk assessments (including sensor SRA).
• Create DQ, IQ, OQ protocols.
• Execute DQ, IQ, OQ.
• Provide technical troubleshooting during PQ and validation.

Requirements

• Over 5 years of experience in CSV (Computer System Validation) or quality control within the pharmaceutical industry.
• Deep knowledge and practical experience with GMP regulations.
• Experience with audit response and communication with regulatory authorities.
• Excellent analytical and project management skills.
• Business-level Japanese and English communication skills.
• Willingness to travel within Japan as needed.

Skills

• Quality Control
• GMP
• Auditing
• SOP Creation
• Risk Assessment
• Project Management
• CSV
• DQ
• IQ
• OQ
• PQ
• Validation
• Root Cause Analysis

Location

• Tokyo
• Remote Work

Work Type

• Hybrid
• Travel

Experience Level

• 5+ years

About the Company

• Medical Devices Engineering Practice focuses on ensuring the safety, reliability, and availability of products for clients in the life sciences industry, while also addressing product functionality and performance development. This practice also handles lifecycle support and evolution, including providing documentation and information assets, assessing environmental impact throughout the product lifecycle against environmental regulations and policies, and integrating renewable energy sources and clean technologies into product and system design. This practice is applicable to the life sciences industry.
• Capgemini Engineering (Engineering R&D Division) is a global leader in engineering and R&D services, combining deep industry knowledge with cutting-edge digital and software technologies to bridge the physical and digital worlds. Leveraging the full capabilities of the Capgemini Group, we accelerate our clients' transition to 'Intelligent Industry'. With 65,000 engineers and scientists across 30 countries, we serve diverse industries including aerospace, defense, automotive, rail, energy, life sciences, telecommunications, and more.
• Capgemini is a global partner for technology transformation, helping companies accelerate their transition to the digital and sustainable worlds, creating tangible impact for organizations and society. With over 55 years of experience, our diverse team of approximately 340,000 members across 50 countries is dedicated to supporting clients' business needs through technology. We offer end-to-end services and solutions, leveraging our expertise in AI, generative AI, cloud, and data, combined with deep industry knowledge and a strong partner ecosystem.
• Capgemini is a global partner supporting business and technology transformation through AI, helping clients envision their future and realize it by integrating AI, technology, and human capabilities. With a strong track record of nearly 60 years, our diverse team of approximately 420,000 members across more than 50 countries provides end-to-end services and solutions. We leverage deep industry knowledge, a robust partner ecosystem, and expertise in strategy, technology, design, engineering, and business operations.

Equal Opportunity

• Capgemini is an equal opportunity employer, encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other legally protected characteristic.