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Quality Auditor - Pharmaceutical/Cosmetics

TokyoOn-site

AI Summary

Performs contract supplier quality audits at pharmaceutical, cosmetics and medical device suppliers in Japan, leading audits, writing reports to client specifications and coordinating schedules. Requires regulatory knowledge of 21 CFR 210/211, EU Vol 4, ISO 22716 and ISO 9001.

About this role

For nearly 30 years, SQA Services has been a leading provider of managed supplier quality services, offering audits, assessments, remote surveillance, corrective actions, remediation, inspections, and engineering solutions to manufacturers across all industries. We deliver these services by deploying a network of highly skilled associates based throughout the United States and in over 90 countries worldwide, ensuring rapid on-site support at your supplier locations. Our associates are expert quality assurance professionals with extensive experience and local expertise, enabling us to represent our clients on-demand and with greater speed and efficiency than our competitors.
We’re hiring a Supplier Quality Auditor who has experience working with cosmetics and pharma regulations. This is a contract opportunity in which you will perform supplier quality audits at various suppliers in Japan. These audits are generally 1-2 days long. You are given the flexibility to accept or reject these assignments according to your own availability.

Key Responsibilities

  • Perform supplier audits at various sites within your region of residence
  • Assure quality in the supply chains of various clients within the pharmaceutical, medical device, cosmetics, biologics, and/or animal health industries
  • Coordinate, prepare, execute, and deliver supplier audits based on your own and the client schedule
  • Utilize your regulatory knowledge of various standards from ISO, CFR, FDA, etc…
  • Respond to the Content team in a timely manner regarding edits/questions to your audit report
  • Write audit reports in accordance with client specifications

    • Required Qualifications

  • 5+ years of hands-on audit experience in pharmaceutical, medical device, and/or biologics industries
  • Has been the lead auditor in at least 10 audits
  • Direct audit experience to 21 CFR 210/211, EU Vol 4, ISO 22716, and ISO 9001
  • Strong communication and writing skills
  • Proven ability to deescalate workplace conflicts effectively
  • Ability to adapt to new technology and software.
  • Willingness to travel regionally

    • Preferred Qualifications

  • Direct audit experience to ISO 17025, ISO 15378, IPEC GDP, ICH Q7 and/or ISO 13485
  • ISO certifications are a plus but not mandatory

    • Skills

    21 CFR 21021 CFR 211Audit Report WritingEU GMP Vol 4FDA RegulationsICH Q7IPEC GDPISO 13485ISO 15378ISO 17025ISO 22716ISO 9001Lead AuditingSupplier Quality Auditing

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