Description
The role serves as a subject matter expert responsible for supporting successful product launches, transfers, and lifecycle changes through efficient and effective project execution.
Responsibilities:
- Provide subject matter expertise for site NPI processes to support successful product launches in compliance with applicable standards and regulations.
- Support the development, maintenance, and continuous improvement of area-specific procedures.
- Execute material management activities to create or modify materials within established timelines.
- Support launch and transfer material maintenance activities to meet agreed milestones and delivery dates.
- Contribute to the minimization of write-offs through NPI support and continuous improvement activities.
- Support coordination across functions in the M-ERP Data Maintenance process.
- Provide technical support for discontinuation of factory codes and related system updates.
- Act as a subject matter expert for NPI and technical transfer activities.
Requirements:
- At least 5 years of experience in pharmaceutical industries.
- Bachelor's degree or equivalent in Scientific field (e.g. Pharmaceutical Chemistry and Technologies, Chemistry, Biology).
- Fluent spoken and written both Japanese and English.
- Knowledge of GMP/GDP and good documentation practices, with experience supporting internal/external audits.
- Strong technical expertise: proven ability to provide deep knowledge on manufacturing, packaging, systems, equipment, and process-related topics to support site operations, product launches, and technology transfers.
- Cross-functional delivery and risk/project management: proven ability to work effectively across functions to support execution of complex projects, manage risks, and deliver activities within agreed timelines.
- Results-oriented mindset and continuous improvement: committed to achieving business and quality objectives through strategic thinking, innovation, and a focus on continuous improvement.
- Problem-solving and critical thinking: ability to analyze complex situations, identify practical solutions, and make informed decisions based on data and metrics.
- Good understanding of advanced technology and smart manufacturing, including application of data science and digital tools.