GMP Validation Consultant / Validation Report Writer- Japan

Job Description
We are supporting a global life sciences consulting company specialising in quality, compliance and validation in hiring a Mid-to-Senior GMP Validation Consultant.
This opportunity suits a validation professional with hands-on experience in process validation, cleaning validation and equipment/facility qualification, together with strong technical writing skills in English and Japanese.
Role Details
Location: Sasayama, Hyogo Prefecture, Japan
Working arrangement: On-site preferred; remote support will also be considered
Engagement: Candidates seeking a GMP Engineer position on a fixed-term or permanent contract may also be considered, depending on their profile.
Target start: By the end of October 2026; immediate availability preferred
Languages: Business-level English and Japanese required
About The Role
You will support the preparation, review and organisation of critical validation documentation for Chemistry, Manufacturing and Controls (CMC) and regulatory submissions. The role combines validation expertise, data review and technical report writing, working closely with local teams to produce accurate, complete and GMP-compliant documentation.
Key Responsibilities
Prepare, compile and review validation documentation supporting CMC and regulatory submissions.
Collect, assess and organise validation data and supporting records.
Author, update and finalise comprehensive validation reports and technical summaries in English.
Review documentation covering process validation, cleaning validation and equipment/facility qualification.
Coordinate with Japanese-speaking teams to gather data, clarify technical information and resolve documentation gaps.
Ensure documentation complies with applicable GMP requirements and internal quality and regulatory guidelines.
Qualifications
Required Experience and Skills
Strong, demonstrated knowledge of current Good Manufacturing Practice (cGMP) requirements.
Hands-on validation experience in a GMP-regulated environment, covering:
Process Validation (PV)
Cleaning Validation
Equipment/Facility Qualification: DQ, IQ, OQ and PQ
Proven experience writing, reviewing and managing technical reports for regulatory filings.
Strong English technical writing and editing skills.
Business-level Japanese for local team communication and data collection.
Ability to review complex validation results and translate them into clear, well-structured reports.
Preferred Experience
Analytical method validation.
International or multi-country regulatory submissions.
Why Is This a Great Opportunity
Global exposure: Work with an international life sciences consulting company on critical validation and regulatory projects.
Meaningful impact: Contribute to GMP compliance and documentation supporting CMC and regulatory submissions.
Flexible engagement: Freelance preferred, with fixed-term or permanent opportunities considered depending on your profile.
Location flexibility: On-site work in Sasayama, Japan, is preferred, with remote support also considered.
Apply your expertise: Combine hands-on validation knowledge with bilingual communication and technical report writing.

Work arrangement
Yes