Quality Auditor, Pharmaceuticals
SQA Services, Inc.
Quality Auditor - Animal Health
SQA Services, Inc.
contract
Posted on:
Location Type: Office
Location: Tokyo • 🇯🇵 Japan
Visit company websiteSalary
💰 $1,600 - $1,700 per year
Job Level
Mid-LevelSenior
About the role
- Perform supplier audits at various sites within Japan (1–2 day audits)
- Assure quality in the supply chains of clients in animal health, pharmaceutical, medical device, cosmetics, and/or biologics industries
- Coordinate, prepare, execute, and deliver supplier audits based on your and the client schedule
- Utilize regulatory knowledge of standards (ISO, CFR, FDA, etc.) during audits
- Write audit reports in accordance with client specifications and respond to Content team edits/questions in a timely manner
- Travel to supplier sites across Japan and manage audit-related logistics
Requirements
- 5+ years of hands-on audit experience in animal health, pharmaceutical, medical device, cosmetics, and/or biologics industries
- Direct audit experience in the animal health industries
- Strong communication and writing skills
- Proven ability to deescalate workplace conflicts effectively
- Ability to adapt to new technology and software
- Willingness to travel
- Preferred: strong experience with FAMI-QS, 21 CFR part 58, 21 CFR part 820, EU GDP, ISO 15378, ISO 17025, 21 CFR part 210/211, ISO 22716
- Preferred: ISO certifications are a plus but not mandatory
Benefits
- Travel expenses reimbursed at cost with receipts per SQA travel policy
- Flexibility to accept or reject audit assignments based on your availability
- SQA helps with audit preparation and proofreads all audit reports
- Equal Opportunity Employer (employment based on merit and qualifications)
ATS Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
audit experienceregulatory knowledgeISO standardsCFR standardsFDA standardsFAMI-QS21 CFR part 5821 CFR part 820ISO 15378ISO 17025
Soft skills
communication skillswriting skillsconflict de-escalationadaptabilityorganizational skills
Certifications
ISO certifications
