Gqp/qms Operations (Japan)

TL;DR

GQP/QMS Operations (Japan): Managing GQP/QMS operations for Japan marketed products, handling product complaints from initiation to close-out for both medicinal products and medical devices with an accent on full documentation to support Japan market release. Focus on documenting changes, deviations, and CAPAs to support products in Japan, ensuring compliance with regulatory requirements.

Location: This role is based out of our Tokyo office with weekly flexibility to support both your professional and personal needs.

Company

hirify.global is a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases.

What you will do

• Ensure accurate complaint intake, troubleshooting, and tracking of complaint data.
• Review complaints for accurate information, regulatory compliance, and unreported adverse events.
• Act as a technical product subject matter expert and troubleshoot complaints.
• Support product/supplier changes, deviations, and CAPAs, assisting with technical write-ups and root cause analysis.
• Assist in maintaining GQP and QMS SOPs.
• Actively work on global and local quality projects.

Requirements

• Minimum 3 years’ experience in a similar role within the pharmaceutical or medical device industry.
• Thorough knowledge of GMP, GQP, and good documentation practice.
• Experience in working with an electronic Quality Management system.
• Must have the ability to meet tight deadlines and be efficient, detail-oriented, flexible, and a self-starter.
• Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
• Bachelor’s degree in life sciences or equivalent through experience.

Culture & Benefits

• Flexible working hours and comprehensive leave system.
• Retirement benefit plan, stock reward system, and employee stock ownership plan (ESPP) participation opportunities.
• Support for career development through internal and external training programs, LinkedIn Learning, and specialized professional training.
• Advanced learning support with AI-powered learning tools and a digital assistant for accessing internal resources.
• Hybrid work environment with the latest technology for seamless collaboration across locations and time zones, and a comprehensive IT support system.