Quality Auditor, Pharmaceuticals
SQA Services, Inc.
Quality Auditor - Cosmetics
SQA Services, Inc.
contract
Posted on:
Location Type: Office
Location: Tokyo • 🇯🇵 Japan
Visit company websiteSalary
💰 $200 - $213 per hour
Job Level
Mid-LevelSenior
About the role
- Perform 1-2 day supplier audits at various sites within Japan
- Assure quality in the supply chains of clients within 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 various standards (ISO, CFR, FDA, etc.)
- Write audit reports in accordance with client specifications and respond to Content team edits/questions in a timely manner
- Include time for preparation, travel, performing the audit, writing the report, and responding until the report is finalized
Requirements
- 5+ years of hands-on audit experience in animal health, pharmaceutical, medical device, cosmetics, and/or biologics industries
- Direct audit experience to EffCI, EU GMP, EU Vol 4, and ISO 22716
- 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 21 CFR part 58, 21 CFR part 820, EU GDP, ISO 15378, ISO 17025
- Preferred: ISO certifications are a plus but not mandatory
Benefits
- Expenses are reimbursed at cost with receipts per SQA travel policy.
- Flexibility to accept or reject audit assignments based on your availability.
- SQA helps with preparation of the audit and proofreads all audit reports.
ATS Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
audit experienceregulatory knowledgeISO standardsCFR standardsFDA standardswriting audit reportsdeescalationadaptability to technology21 CFR part 5821 CFR part 820
Soft skills
strong communication skillswriting skillsconflict resolutionadaptabilitytime management
Certifications
ISO certifications
