Global Quality Assurance Auditor, Pharmacovigilance
Core
Provide QA auditing and Global Compliance support for Pharmacovigilance (PV) functions and GMP manufacturing sites within the Pharmaceutical Diagnostics business.
Role type
Senior Quality Assurance Auditor (Pharmacovigilance)
Builds
Compliance assurance for PV QA processes and GMP manufacturing sites
Domain
Pharmaceutical industry / Pharmacovigilance / GMP
Required skills
Auditing, Regulatory compliance (FDA, MHRA, EMEA), Risk analysis, CAPA management, Vendor qualification, Quality management systems (QMS), Trend analysis, Change control
Preferred skills
Project management, Quality tools application, Regulatory agency interfacing, Process improvement, Influence and negotiation
Technologies
GPvP, cGMP, GDP
Responsibilities
Plan, prepare, and execute internal and external audits for Quality Risk Assessment (QRA); Ensure remediation of identified actions and observations; Conduct risk analysis of systems and processes; Support regulatory inspections as a functional QA subject matter expert; Perform trend analysis of audit data; Manage vendor qualification and surveillance activities; Participate in QMS improvements; Provide guidance on CAPA setup and Quality Event records; Monitor regulatory guidelines and implement changes.
Seniority
Senior, hands-on IC
