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Quality Assurance Manager
12 hours ago
Clevry Sweden AB is a dynamic company that values expertise and innovation. We are seeking a Senior GxP Auditor to join our team and support the development of our global risk-based audit strategy. As a member of our Quality Assurance team, you will play a vital role in ensuring compliance with GMP/GDP regulations.
Job SummaryThe Senior GxP Auditor will be responsible for leading and conducting external GxP audits, as well as performing internal audits/self-inspections. You will work closely with cross-functional teams to maintain the highest standards in quality and regulatory compliance.
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).
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