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SQA Services

Posted 29 days ago

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Quality Auditor - Pharma/Med Device

BeijingRemoteContract

AI Summary

A contract-quality auditor role focusing on performing supplier quality audits for pharma/medical device clients across China, with regulatory-led report writing and client coordination.

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/Med Device Quality Supplier Auditor. This is a contract opportunity in which you will perform supplier quality audits at various suppliers in China. 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, China GMP, 21 CFR part 820, and ISO 13485
  • 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, ICH Q7 and/or Canada GMP
  • ISO certifications are a plus but not mandatory

    • Skills

    21 CFR Part 210/211Audit PlanningAudit ReportingBiologics Quality SystemsChina GMPCross-border AuditingDeescalationEU V4FDA RegulationsGMP/GLP/GCP FamiliarityICH Q7IPECISO 13485ISO 15378ISO 17025ISO CertificationsLead Auditor ExperienceMedical Device Quality SystemsPharmaceutical Quality SystemsQuality SystemsRegulatory KnowledgeRegulatory Standards ComplianceSupplier AuditingWriting And Editing Audit Reports

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