Lead Auditor (GxP) - Internal or Freelance
Core
Performing GxP audits in the EU for pharmaceutical, medical devices, and cosmetics clients to ensure regulatory compliance.
Role type
Lead Auditor (GxP)
Builds
Audit reports and CAPA evaluations for clients in the healthcare assurance sector.
Domain
Life Sciences / Pharmaceutical / Medical Devices / Cosmetics
Deliverable
client delivery
Required skills
GMP/GDP knowledge, ISO 9001/15378/13485 standards, EU/US FDA regulations, supplier auditing, CAPA evaluation, analytical mindset
Preferred skills
API manufacturing experience, sterile products manufacturing experience
Technologies
MS Word, MS Excel
Responsibilities
Conducting GxP audits across EU, preparing audit reports, evaluating CAPA plans, collaborating on continuous improvement
Seniority
Senior, hands-on IC
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