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QA Auditor – GxP (H/F/X)

March 2nd 2021

At Univercells, we are on a mission to make health equally accessible to all. We work every day to reinvent biomanufacturing processes, and develop or integrate the next innovative technologies. Through the combination of process development and engineering expertise, we create synergies to deliver game-changing production capacities to achieve our mission: Biologics available and affordable to all!

Mission Description

  • You will prepare, conduct and document on-site/remote/paper-based GxP audits, issues reports, you will also approve CAPA plans and ensure implementation monitoring in cooperation with relevant internal stakeholders
  • You will be involved and perform risk assessments and you will keep informed all relevant stakeholders of critical findings resulting from audits.
  • You will participate in due diligence of new third parties/projects in quality-related concerns. 
  • You will support the internal QA teams with the preparation of major client audits and health authority inspections and will perform audit readiness.
  • You will support Procurement, Supply Chain, and relevant QA teams with the introduction of new suppliers/contractors/partners.
  • You will drive continuous quality and compliance improvement mindset at the group and subsidiary level and third parties, such to ensure compliance with cGMPs.
  • You will provide adequate QA/QMS reporting on the audit-related activities.
  • You will promote and ensure the application of the company’s values and will act as the company’s representative by showing respect and being an ambassador for it.

Candidate profile

  • Master’s degree in life sciences-related field.
  • Minimum 5 years of relevant experience in auditing in the biopharmaceutical industry, with a minimum of 30 audits performed as lead auditor.
  • Certified auditor is desirable.
  • Strong working knowledge of cGMPs covering worldwide territories (at least USA and EU) and international organizations (WHO).
  • Experience preparing technical/complex written materials that are accurate, clear, logical, well organized.
  • Excellent English, both written and spoken (native level is an asset)
  • Excellent interpersonal written and oral communication skills
  • Independent and Self-organized
  • Ability to travel worldwide, also on short notice.

Offer

For more information please contact to Univercells

Contact Details


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