Posted 1 month ago

Quality Auditor - Pharmaceutical/Medical Device

TokyoOn-site

AI Summary

Pharma Quality Auditor conducts supplier quality audits across pharmaceutical and medical-device suppliers, ensuring regulatory compliance and report-writing per client specs.

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 Pharma Quality Auditor. 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 part 210/211, EU Vol 4, 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 Part 210/211Audit PlanningCFRCorrective ActionsDeescalation Of ConflictsEU Vol 4FDA InspectionsFDA RegulationsICH Q7IPEC GDPISO 13485ISO 15378ISO 17025ISO 9001ISO Certifications (plus)Registry ManagementRegulatory KnowledgeReport WritingSupplier AuditsTravel Coordination

Quality Auditor - Pharmaceutical/Medical Device

About this role

Key Responsibilities

Required Qualifications

Preferred Qualifications

Skills

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