Lead Auditor- Healthcare
Core
Conduct supplier audits for pharmaceutical, medical device, and cosmetic companies to ensure compliance with regulatory standards and quality management systems.
Role type
Senior Lead Auditor (Quality Management Systems)
Builds
Audit reports, CAPA evaluations, and compliance assessments for global supply chains.
Domain
Healthcare, Pharmaceuticals, Medical Devices, Cosmetics
Deliverable
client delivery
Required skills
Conducting supplier audits, Technical audit report writing, Knowledge of EU GMP, ISO 9001, ISO 13485, ISO 15378, ISO 22716, CFR 21, EU GDP, IPEC guidelines, Analytical capacity, Autonomy, Attention to detail
Preferred skills
Quality Management System certification, Computer System Validation, Six Sigma, ISO certification
Technologies
Microsoft Office, LIMS, SAP, CDS system
Responsibilities
Manage pre-audit documents and agendas, Conduct on-site audits, Draft audit reports and comments, Evaluate CAPA plans, Report non-compliances to QA, Collaborate with sales and planning teams, Review audit reports with customers
Seniority
Senior, hands-on IC
