CSV Project Manager

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.

Requirements:

• 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.