We are looking for a bilingual, Japanese-speaking Computer System Validation (CSV) Project Manager for an exciting healthcare company.
Snapshot of the role's responsibilities:
- Resolution of fundamental CSV compliance issues
- Align with e‐Compliance on project management and life-cycle documentation for GxP projects
- Managing risks and validating deliverables for GxP and tested for non‐GxP in line with SOPs and CSV requirements
- Deviation reporting; collecting and managing the user requirements from various departments into specifications and details, including support to establish user requirements, IQ/OQ/PQ documentation
- Implementing document traceability, retaining document repository (Document Navigator) and approved in accordance to the prescribed SOPs
- Remote work available.
- Technical university degree (Engineering, Chemistry, Informatics,..)
- Strong experience in pharmaceutical companies doing, eg, equipment validation, computerised systems validation, quality control
- Knowledge of GMPs requirements
- Knowledge of ALCOA and GAMP practices
- Bilingual: Japanese (N1 to native); and English (at least TOEIC 750/CEFR B2)
- Availability to Travel up to 20% of working week.
About the company:
- Started in 1998 with global operations; since 2017 in Japan and growing with strength and steadiness
- Strong diversity-and-inclusion: women-owned
- Complete quality solution provider for GCP, GLP, GMP & GDP areas in the Life Science Industry
- Supporting clients in maintaining compliance with the latest regulations.