GMP / QMS Consultant

Tokyo
Life Sciences – Consumer /
Staff: Full-Time Hourly /
On-site
For almost 30 years, SQA Services has been a premier leader in providing managed supplier quality services for audits,  assessments, remote surveillance  assessments, corrective actions, remediation, inspections, and engineering to manufacturers within all industries. We deliver services by deploying associates who are located throughout the United States and in 90+ countries around the world to your supplier sites. Our associates are expert quality assurance professionals with broad experience and local knowledge who can represent our clients on-demand and on-site faster than our competitors.

This role is for a 12-18 month contract on full time hours. This will require being onsite in Tokyo 5 days a week but it can shift to a hybrid role to being onsite as needed.

Responsibilities

    • Collaborate in weekly meetings, work with stakeholders for quality implementations
    • Ensure SOP's and polices are executed to plan.
    • Write technical SOP's as necessary.
    • Implement GMP QMS at a corporate level.
    • Manage projects and be the middle person for coordination; excellent communication skills in Japanese and English.

Qualifications

    • 4+ years of experience in the pharmaceutical, consumer, quasi drugs, and/or medical device industries
    • Good knowledge of GMP's, investigations, corrective actions, lab management, etc.
    • Experience working in a laboratory or understanding of laboratory controls
    • Quality Engineering experience preferred
    • Bilingual English and Japanese
    • Experience with ISO 9001, ISO 22000, ISO 22716, GDP, and 21 CFR part 210/211
$75 - $85 an hour