GMP Auditor and Trainer

4 days ago

Stockholm, Stockholm, Sweden Clevry Full time
Job Description

We are seeking a Senior GxP Auditor to join our team at Clevry. The successful candidate will be responsible for developing and implementing a global audit strategy and program, conducting external audits of suppliers and service providers, and performing internal audits/self-inspections.

The ideal candidate will possess a strong background in GMP/GDP audits/inspections, experience as a GMP Inspector or Auditor in Biotechnology and Sterile Manufacturing, and exemplary knowledge of EU/US/RoW GMP/GDP regulations.

Responsibilities:

  1. Develop and implement 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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