About this role
About the Role Capgemini's Automation Quality Management Consultant leads quality assurance and regulatory compliance at client pharmaceutical manufacturing processes. As a specialist in GMP, you will drive the design, maintenance, and continuous improvement of GMP-compliant quality management systems to ensure product quality and patient safety. What You'll Do
- Lead internal and external audits and develop corrective actions and responses
- Assess, evaluate, and implement improvements to the Quality Management System
- Create and implement SOPs based on regulatory requirements; develop regional/site SOP templates as needed
- Perform GMP risk assessments and optimize quality management processes
- Collaborate with client quality teams to resolve issues and drive continuous improvement
- Establish and maintain a comprehensive quality management framework across client processes; archive relevant documents
- Support change control processes and deviation investigations (root cause analysis)
- Manage project engineering and controls: prepare equipment specifications and system requirements (e.g., URS), develop functional specifications, execute work instructions per statements of work
- Execute DQ/IQ/OQ protocols; support PQ and validation troubleshooting; assist with requalification
- Conduct GMP risk assessments, including sensor-based risk assessments What We're Looking For
- 5+ years of CSV (computer systems validation) or quality management experience in the pharmaceutical industry
- Deep knowledge of GMP regulations and practical hands-on experience
- Experience handling audits and communicating with regulatory authorities
- Excellent analytical and project management skills
- Business-level Japanese and English communication
- Willingness to travel within Japan domestically as required Nice to Have
- Experience in Medical Devices Engineering domain and lifecycle support for life sciences products
- Enthusiasm for continuous learning and applying engineering solutions to quality management challenges