Regulatory Compliance Expert

4 days ago


Stockholm, Stockholm, Sweden Clevry Full time
About the Role

As a Senior GxP Auditor at Clevry, you will play a critical role in ensuring compliance with regulations such as GMP and GDP. Your responsibilities will include developing a global risk-based audit strategy and program, planning and leading external audits of suppliers and service providers, and performing internal audits/self-inspections.

The ideal candidate will have a strong background in GMP/GDP audits/inspections and experience as a GMP Inspector or Auditor in Biotechnology and Sterile Manufacturing. You will also possess exemplary knowledge of EU/US/RoW GMP/GDP regulations and strong verbal and written communication skills.

This is an excellent opportunity to join a dynamic team and contribute to maintaining quality and regulatory standards within the pharmaceutical industry.

Key Responsibilities:

  1. Develop a global risk-based audit strategy and program.
  2. Plan, lead, conduct, document, and follow up on external audits of suppliers and service providers.
  3. Perform internal audits/self-inspections as Lead or Co-Auditor.
  4. Provide guidance and recommendations for compliance.
  5. Elevate critical findings and ensure appropriate corrective actions.
  6. Prepare regular reports, including audit trends and performance metrics.
  7. Support inspections and partner audits.
  8. Maintain expertise in FDA, EU, and ICH regulations.
  9. Author SOPs related to audit procedures.
  10. Offer consulting services for training and continuous improvement projects.


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