Senior GxP Compliance Specialist

5 hours ago


Stockholm, Stockholm, Sweden Clevry Sweden AB Full time

At Clevry Sweden AB, we are seeking a highly skilled Senior GxP Auditor to support the development of our global risk-based audit strategy. This key role is responsible for ensuring compliance with GMP/GDP regulations while collaborating with cross-functional teams to maintain the highest standards in quality and regulatory compliance.

Job Description

We are looking for an experienced professional to lead and conduct external GxP audits of CMOs, suppliers, and service providers. The successful candidate will also perform internal audits/self-inspections, provide regulatory guidance and recommendations for compliance, and escalate critical findings.

Key Responsibilities:
  • Develop and support a global risk-based audit strategy and program
  • Plan, lead, conduct, document, and follow up on external GxP audits of CMOs, suppliers, and service providers
  • Perform internal audits/self-inspections as Lead or Co-Auditor
  • Provide regulatory guidance and recommendations for compliance
  • Escalate critical findings and ensure appropriate corrective and preventive actions (CAPA)

The ideal candidate will possess a strong background in GMP/GDP audits/inspections and have experience as a GMP Inspector or Auditor in Biotechnology and Sterile Manufacturing (Drug and Finished Products). Excellent knowledge of EU/US/RoW GMP/GDP regulations is essential.



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